Clinical Trials

PF-07220060 (atirmociclib) is undergoing evaluation in numerous clinical trials spanning Early Phase I through Phase IV to assess its safety, efficacy, and pharmacokinetics. Featuring active, recruiting, completed, and terminated protocols, these studies primarily investigate advanced or metastatic ER+ HER2- breast cancer, solid tumors, non-small cell lung cancer, prostate cancer, liposarcoma, and healthy volunteers. The research is sponsored by industry leaders such as Pfizer, Arvinas Estrogen Receptor Inc., and Relay Therapeutics, as well as academic centers including the Dana-Farber Cancer Institute.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07802626 NOT_YET_RECRUITING
HR Positive/HER-2 Negative Breast Cancer
SWOG Cancer Research Network
2026-10-30 PHASE3
NCT05977036 RECRUITING
Metastatic Breast Cancer; Unresectable Breast Cancer
Washington University School of Medicine
2024-09-25
NCT07213206 NOT_YET_RECRUITING
Breast Cancer
Fudan University
2025-10-07 PHASE3
NCT07214532 RECRUITING
Breast Neoplasms; Carcinoma, Ductal, Breast; Receptors, Estrogen (for ER-positive Requirement)
Natera, Inc.
2026-05-08
NCT07729046 NOT_YET_RECRUITING
Metastatic Invasive Breast Cancer; Resistant Breast Cancer; ER+, HER2-, Metastatic Breast Cancer
University of California, San Diego
2027-07 PHASE2
NCT06790693 RECRUITING
Breast Cancer
Hoffmann-La Roche
2025-04-09 PHASE3
NCT07432178 NOT_YET_RECRUITING
Breast Cancer
Fudan University
2026-03-31 PHASE3
NCT05933395 RECRUITING
Advanced Breast Cancer
Dartmouth-Hitchcock Medical Center
2024-09-23 PHASE2
NCT06996093 NOT_YET_RECRUITING
Breast Cancer
Fudan University
2025-06-02 PHASE3
NCT07005557 NOT_YET_RECRUITING
Breast Cancer; Adjuvant Therapy
Fudan University
2025-06-15 PHASE3
NCT07191717 RECRUITING
Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Invasive Breast Carcinoma; Localized Estrogen Receptor-Positive Breast Carcinoma; Localized Human Epidermal Growth Factor Receptor (HER2)-Negative Breast Carcinoma
Jonsson Comprehensive Cancer Center
2026-05-18 PHASE2
NCT06380751 RECRUITING
Advanced Breast Cancer
AstraZeneca
2024-08-01 PHASE3
NCT06120283 RECRUITING
Advanced Solid Tumor; Advanced Breast Cancer; Metastatic Breast Cancer; Hormone-receptor-positive Breast Cancer; Hormone Receptor Positive Breast Carcinoma; Hormone Receptor Positive Malignant Neoplasm of Breast; HER2-negative Breast Cancer; Hormone Receptor Positive HER-2 Negative Breast Cancer
BeOne Medicines
2023-12-01 PHASE1
NCT07222267 RECRUITING
Breast Cancer; Advanced Solid Tumor
BeOne Medicines
2025-12-11 PHASE1
NCT04606446 RECRUITING
Locally Advanced or Metastatic ER+ HER2- Breast Cancer; Locally Advanced or Metastatic Castration-resistant Prostate Cancer; Locally Advanced or Metastatic Non-small Cell Lung Cancer
Pfizer
2020-11-16 PHASE2
NCT07019363 RECRUITING
Breast Cancer; Adjuvant Therapy
Fudan University
2025-06-15 PHASE3
NCT07527806 NOT_YET_RECRUITING
Breast Cancer
Peking University Cancer Hospital & Institute
2026-05-01 PHASE2
NCT07174336 RECRUITING
Breast Neoplasms; Neoplasm Metastasis
Eli Lilly and Company
2025-12-22 PHASE3
NCT07492641 RECRUITING
HR+/HER2- Breast Cancer
BeOne Medicines
2026-05-22 PHASE3
NCT07340658 NOT_YET_RECRUITING
Advanced, Metastatic Breast Cancer
Rovi Pharmaceuticals Laboratories
2026-08 PHASE3
NCT06760637 ACTIVE_NOT_RECRUITING
Breast Cancer
Pfizer
2025-01-06 PHASE3
NCT07419867 NOT_YET_RECRUITING
Breast Cancer
Fudan University
2026-03-01 PHASE2
NCT04750928 RECRUITING
Neurofibromatosis 1
National Cancer Institute (NCI)
2021-11-29 PHASE1; PHASE2
NCT07382687 NOT_YET_RECRUITING
Breast Cancer
Fudan University
2026-02-26 PHASE3
NCT06997029 RECRUITING
Advanced Solid Tumor; Advanced Breast Cancer; Advanced Ovarian Cancer
Bristol-Myers Squibb
2025-08-01 PHASE1
NCT07235176 RECRUITING
Advanced ER+/HER2- Breast Cancer
Qilu Pharmaceutical Co., Ltd.
2026-01-16 PHASE1; PHASE2
NCT06044623 RECRUITING
Metastatic Breast Cancer; Advanced Breast Cancer; Quality of Life; Toxicity; Older Patients
Region Örebro County
2024-04-01 PHASE3
NCT07766018 RECRUITING
Breast Cancer
Stemline Therapeutics, Inc.
2026-08 PHASE2
NCT05940493 RECRUITING
Meningioma
Nader Sanai
2025-03-24 PHASE2
NCT07100106 RECRUITING
Breast Cancer
Genentech, Inc.
2025-10-07 PHASE1; PHASE2
NCT06377852 RECRUITING
Metastatic Breast Cancer
American Society of Clinical Oncology
2024-10-29 PHASE3
NCT06680921 ACTIVE_NOT_RECRUITING
Locally Advanced or Metastatic Breast Cancer
Jiangsu Simcere Pharmaceutical Co., Ltd.
2024-11-14 PHASE3
NCT06680596 ENROLLING_BY_INVITATION
Breast Cancer Metastatic; Breast Cancer Stage IV
UNICANCER
2025-07-30 PHASE2
NCT04968964 RECRUITING
Breast Cancer; Cancer of the Breast
Washington University School of Medicine
2022-03-07
NCT06145308 RECRUITING
Salivary Gland Carcinoma; Precision Therapy
Peking Union Medical College
2023-08-15 PHASE2
NCT06062498 RECRUITING
Estrogen-receptor-positive Breast Cancer; HER2/Neu-Negative Breast Cancer; Advanced Breast Cancerv; Metastatic Breast Cancer
Northwestern University
2023-09-29 PHASE2
NCT06113809 RECRUITING
Sarcoma
John Rieth
2024-02-01 PHASE1
NCT05625087 ACTIVE_NOT_RECRUITING
Breast Cancer Stage IV
UNICANCER
2023-10-19 PHASE2
NCT07037199 RECRUITING
Advanced Breast Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2025-08-18 PHASE2
NCT07666555 RECRUITING
Breast Cancer
Fudan University
2026-06-06 PHASE2
NCT07198724 RECRUITING
Metastatic Breast Cancer; HER2 Low Breast Carcinoma; HER2-negative Breast Cancer; Breast Cancer; Breast Cancer Female
Kristina A. Fanucci
2025-11-17 PHASE1; PHASE2
NCT07782840 NOT_YET_RECRUITING
Breast Cancer
Hebei Medical University Fourth Hospital
2026-10-01 PHASE2
NCT06982521 RECRUITING
PIK3CA Mutation; HER2- Negative Breast Cancer; Hormone Receptor Positive Tumor; Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer
Relay Therapeutics, Inc.
2025-08-26 PHASE3
NCT07215364 RECRUITING
Early-stage Breast Cancer
Spanish Breast Cancer Research Group
2026-07-02
NCT07491380 RECRUITING
Breast Cancer
Institut Curie
2026-06-23
NCT07366112 RECRUITING
Hormone Receptor-Positive Breast Cancer; High-risk Breast Cancer; Early-Stage Breast Cancer; HER2-negative Breast Cancer; ctDNA Monitoring
Peking University People's Hospital
2026-04-20 PHASE2
NCT07235618 NOT_YET_RECRUITING
Locally Advanced or Metastatic Breast Cancer
Sun Yat-sen University
2026-01-05 PHASE2
NCT06764186 ACTIVE_NOT_RECRUITING
Locally Advanced or Metastatic Breast Cancer
AstraZeneca
2025-01-07 PHASE3
NCT05601440 RECRUITING
Breast Cancer
Canadian Cancer Trials Group
2023-06-13 PHASE2
NCT05508906 RECRUITING
Metastatic Breast Cancer; ER-positive Breast Cancer; HER2-negative Breast Cancer; Breast Cancer; Locally Advanced Breast Cancer
Olema Pharmaceuticals, Inc.
2022-08-31 PHASE1
NCT07227233 RECRUITING
Breast Cancer
University of California, San Diego
2026-03-31 PHASE2
NCT04862663 ACTIVE_NOT_RECRUITING
Locally Advanced (Inoperable) or Metastatic Breast Cancer
AstraZeneca
2021-05-10 PHASE3
NCT07290166 NOT_YET_RECRUITING
Breast Cancer
Fudan University
2025-12-31 PHASE2
NCT06612814 ACTIVE_NOT_RECRUITING
Breast Cancer Metastatic
Zhimin Shao
2024-09-01 PHASE3
NCT06650748 ENROLLING_BY_INVITATION
Breast Cancer; Early-stage Breast Cancer
Peking University
2025-05-01 PHASE2
NCT07137871 RECRUITING
Breast Cancer Metastatic
The University of Texas Health Science Center at San Antonio
2025-10-02 PHASE1
NCT06382948 RECRUITING
Advanced Breast Cancer; ER-positive Breast Cancer; HER2-negative Breast Cancer; ESR1 Gene Mutation
MedSIR
2024-12-05 PHASE3
NCT07180160 RECRUITING
Advanced Breast Cancer
Wenjin Yin
2025-09-25 PHASE2
NCT03439735 ACTIVE_NOT_RECRUITING
Breast Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2018-07-20 PHASE2
NCT07490236 RECRUITING
Trilaciclib; CDK4/6-dependent Solid Tumors
Hebei Medical University Fourth Hospital
2023-01-01 PHASE1
NCT05181033 RECRUITING
Breast Cancer
National University Hospital, Singapore
2021-12-27 PHASE2
NCT07029399 RECRUITING
HR+ Breast Cancer; Triple Negative Breast Cancer (TNBC); CCNE1 Amplified Advanced Solid Tumors; HR+ HER2- Breast Cancer
NiKang Therapeutics, Inc.
2025-03-25 PHASE1
NCT07258108 RECRUITING
Breast Cancer
Sun Yat-sen University
2025-11-13 PHASE2
NCT07062965 RECRUITING
Breast Cancer
Pfizer
2025-08-05 PHASE3
NCT04469764 RECRUITING
Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
Jonsson Comprehensive Cancer Center
2020-10-16 PHASE2
NCT05372640 RECRUITING
Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic NUT Carcinoma; Unresectable Breast Carcinoma; Unresectable Malignant Solid Neoplasm; Unresectable NUT Carcinoma
National Cancer Institute (NCI)
2023-08-10 PHASE1
NCT07117630 RECRUITING
Breast Cancer
Fudan University
2025-09-25 PHASE2
NCT04920708 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer; ER+ Breast Cancer; Advanced Breast Cancer
Royal Marsden NHS Foundation Trust
2022-12-28 PHASE2
NCT05113537 RECRUITING
Castration-Resistant Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8; Metastatic Castration-resistant Prostate Carcinoma; Metastatic Castration-resistant Prostate Cancer
Vadim S Koshkin
2022-07-08 PHASE1; PHASE2
NCT05216432 RECRUITING
PIK3CA Mutation; Solid Tumor, Adult; HER2-negative Breast Cancer; Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; Unresectable Solid Tumor
Relay Therapeutics, Inc.
2021-12-08 PHASE1
NCT07446686 NOT_YET_RECRUITING
Breast Cancer
Guizhou Provincial People's Hospital
2026-04-01 EARLY_PHASE1
NCT06247995 ACTIVE_NOT_RECRUITING
Breast Cancer
Novartis Pharmaceuticals
2024-08-14 PHASE1; PHASE2
NCT05986071 NOT_YET_RECRUITING
Breast Cancer
Institut Paoli-Calmettes
2024-05-01 PHASE1; PHASE2
NCT07252726 RECRUITING
Metastatic Breast Cancer; Metastatic Prostate Cancer
Ottawa Hospital Research Institute
2026-02-02 PHASE4
NCT05691400 WITHDRAWN
CYP3A4*22
University of Michigan Rogel Cancer Center
2024-03 PHASE4
NCT06126276 RECRUITING
Malignant Female Reproductive System Neoplasm; Malignant Solid Neoplasm; Recurrent Malignant Female Reproductive System Neoplasm; Recurrent Malignant Solid Neoplasm
National Cancer Institute (NCI)
2024-05-07 PHASE2
NCT06065748 RECRUITING
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Hoffmann-La Roche
2023-12-11 PHASE3
NCT06447623 RECRUITING
Advanced Breast Cancer; HR+/HER2- Breast Cancer
Fudan University
2024-02-01 PHASE3
NCT07173556 NOT_YET_RECRUITING
Advanced Breast Cancer
Qilu Pharmaceutical Co., Ltd.
2025-09 PHASE1; PHASE2
NCT05038735 ACTIVE_NOT_RECRUITING
Breast Cancer
Novartis Pharmaceuticals
2021-12-17 PHASE3
NCT06481956 ENROLLING_BY_INVITATION
HER2-positive Advanced Breast Cancer
Zheng Yabing
2023-10-25 PHASE2
NCT06207734 RECRUITING
Breast Cancer
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
2024-01-17 PHASE2
NCT03310879 RECRUITING
Cancer
Dana-Farber Cancer Institute
2017-11-21 PHASE2
NCT06486883 RECRUITING
Advanced Breast Cancer; Advanced Breast Carcinoma; Hormone Receptor Positive Breast Carcinoma
MedSIR
2025-06-30 PHASE2
NCT04553133 ACTIVE_NOT_RECRUITING
Small Cell Lung Cancer; Ovarian Cancer; Breast Cancer
Pfizer
2020-09-16 PHASE2
NCT06556862 NOT_YET_RECRUITING
HR+/HER2- Advanced Breast Cancer
Beijing 302 Hospital
2025-10-01 PHASE2
NCT03065062 SUSPENDED
Lung Cancer Squamous Cell; Solid Tumors; Head & Neck Cancer; Pancreatic Cancer
Dana-Farber Cancer Institute
2017-02-28 PHASE1
NCT05870579 ACTIVE_NOT_RECRUITING
Breast Cancer
Novartis Pharmaceuticals
2023-11-13 PHASE1
NCT07130643 ACTIVE_NOT_RECRUITING
HR+/HER2- Breast Cancer
Xinhong Wu, PhD
2024-12-20 PHASE2
NCT05860465 RECRUITING
Locally Advanced or Metastatic Breast Cancer
Shanghai Pharmaceuticals Holding Co., Ltd
2023-09-08 PHASE2; PHASE3
NCT05305924 RECRUITING
ER-Positive Breast Cancer; HER2-negative Breast Cancer
The Methodist Hospital Research Institute
2021-02-25 PHASE2
NCT04486911 ACTIVE_NOT_RECRUITING
Breast Cancer
Shengjing Hospital
2020-07-27 PHASE2
NCT07163481 NOT_YET_RECRUITING
Stage IV (Metastatic) Breast Cancer
Hunan Cancer Hospital
2025-10 PHASE1
NCT05646862 RECRUITING
Breast Cancer
Hoffmann-La Roche
2023-06-07 PHASE3
NCT05596409 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer
Stemline Therapeutics, Inc.
2023-05-19 PHASE2
NCT06016738 ACTIVE_NOT_RECRUITING
Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer; ER Positive Breast Cancer; HER2 Negative Breast Carcinoma
Olema Pharmaceuticals, Inc.
2023-11-16 PHASE3
NCT03090165 ACTIVE_NOT_RECRUITING
Triple Negative Breast Cancer
Kari Wisinski
2018-05-07 PHASE1; PHASE2
NCT06929325 NOT_YET_RECRUITING
HR+/HER2- Advanced/Metastatic Breast Cancer
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2025-04 PHASE3
NCT04557449 ACTIVE_NOT_RECRUITING
Liposarcoma; Prostate Cancer; Breast Neoplasms; Adenocarcinoma of Lung
Pfizer
2020-09-23 PHASE2
NCT06959979 RECRUITING
Medulloblastoma, Childhood
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
2024-11-25 EARLY_PHASE1
NCT05262400 ACTIVE_NOT_RECRUITING
Breast Cancer; Solid Tumors
Pfizer
2022-03-14 PHASE1; PHASE2
NCT04305834 RECRUITING
Anatomic Stage IV Breast Cancer AJCC v8; Hormone Receptor Positive Breast Carcinoma; Metastatic Breast Carcinoma; Prognostic Stage IV Breast Cancer AJCC v8
City of Hope Medical Center
2020-03-25 PHASE2
NCT05251714 ACTIVE_NOT_RECRUITING
Advanced Solid Tumor; Breast Cancer
Treadwell Therapeutics, Inc
2022-05-27 PHASE1; PHASE2
NCT05826964 ACTIVE_NOT_RECRUITING
Breast Cancer; ER-positive Breast Cancer; HER2-negative Breast Cancer; Metastatic Breast Cancer
University of Miami
2023-06-12 PHASE2
NCT07215078 COMPLETED
Healthy Volunteer
Pfizer
2025-10-08 PHASE1
NCT05949541 RECRUITING
Breast Cancer; Advanced Breast Cancer
Fudan University
2023-07-26 PHASE2
NCT05501886 ACTIVE_NOT_RECRUITING
Breast Cancer
Celcuity Inc
2022-12-08 PHASE3
NCT07214662 TERMINATED
Breast Cancer
Genentech, Inc.
2026-01-13 PHASE1
NCT04438824 ACTIVE_NOT_RECRUITING
Well-differentiated/Dedifferentiated Liposarcoma
Memorial Sloan Kettering Cancer Center
2020-06-17 PHASE2
NCT06702618 ACTIVE_NOT_RECRUITING
Breast Cancer
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
2025-02-20 PHASE2
NCT07409298 ENROLLING_BY_INVITATION
CDK4/6 Inhibitors; Depression Anxiety Disorder; Breast Cancer
Tianjin Medical University Cancer Institute and Hospital
2025-07-05
NCT04010357 COMPLETED
Small-cell Lung Cancer; Large Cell Neuroendocrine Carcinoma of the Lung; Extrapulmonary Small Cell Carcinoma
Case Comprehensive Cancer Center
2020-01-13 PHASE2
NCT06570031 COMPLETED
Hormone Receptor-positive Breast Cancer; HER2-negative Breast Cancer; Metastatic Breast Cancer; Recurrent Breast Cancer
Ono Pharmaceutical Co., Ltd.
2021-11-09 PHASE1
NCT05969184 COMPLETED
Breast Neoplasm Female
Peking University Cancer Hospital & Institute
2021-12-12 PHASE2
NCT06253195 COMPLETED
Advanced Solid Tumor; Metastatic Solid Tumor; Hormone-receptor-positive Breast Cancer; Breast Cancer; Metastatic Breast Cancer; Hormone Receptor Positive Malignant Neoplasm of Breast; HER2-negative Breast Cancer
BeOne Medicines
2024-04-01 PHASE1
NCT03285412 ACTIVE_NOT_RECRUITING
Breast Cancer
Massachusetts General Hospital
2017-12-12 PHASE2
NCT05266105 ACTIVE_NOT_RECRUITING
Breast Cancer
Olema Pharmaceuticals, Inc.
2021-12-10 PHASE1
NCT06105632 ACTIVE_NOT_RECRUITING
Advanced or Metastatic Breast Cancer
Pfizer
2024-01-09 PHASE2
NCT06585969 WITHDRAWN
Metastatic Breast Cancer; ER-positive Breast Cancer; Luminal B; Her2 Enriched; Basal Like
Danish Breast Cancer Cooperative Group
2026-01-01 PHASE3
NCT05536128 RECRUITING
Advanced Breast Cancer
Seoul National University Hospital
2022-12-31 PHASE2
NCT06750848 NOT_YET_RECRUITING
Advanced Breast Cancer
Jundong Wu
2024-12-20 PHASE2
NCT05861830 UNKNOWN
Advanced Breast Cancer
Peking Union Medical College Hospital
2023-05-15 PHASE3
NCT06810492 NOT_YET_RECRUITING
Breast Cancer Stage III; Breast Cancer Stage II
Hongmei Zheng, PhD
2025-04-01
NCT05586841 COMPLETED
HR+/HER2- Advanced Breast Cancer
Beijing 302 Hospital
2022-10-01 PHASE1
NCT04819243 RECRUITING
Premenopausal HR+/HER2- Metastatic Breast Cancer
Samsung Medical Center
2021-08-25 PHASE2
NCT06176534 RECRUITING
Advanced Breast Cancer; Treatment; HR Low/HER2 Negative
Henan Cancer Hospital
2024-01-01 PHASE2
NCT06363734 RECRUITING
Non-small Cell Lung Cancer; EGFR Activating Mutation; Cell Cycle Deregulation; EGFR-TKI Resistant Mutation
Tianjin Medical University Cancer Institute and Hospital
2024-04-09 PHASE2
NCT05190094 RECRUITING
Hormonal Receptors Positive, HER2 Negative, Advanced Breast Cancer
International Cancer Research Group, United Arab Emirates
2022-12-20 PHASE2
NCT06307249 RECRUITING
Cancer; Solid Tumor; Colorectal Cancer; Breast Cancer; Ovarian Cancer; Lung Cancer; Targeted Therapy; Chemotherapy; Immunotherapy; Precision Therapy
Lebanese University
2023-02-15 PHASE1
NCT07160738 COMPLETED
Healthy Adults
Pfizer
2025-09-22 PHASE1
NCT03891784 ACTIVE_NOT_RECRUITING
Advanced Digestive System Neuroendocrine Neoplasm; Digestive System Neuroendocrine Tumor; Foregut Neuroendocrine Tumor; Hindgut Neuroendocrine Tumor; Locally Advanced Unresectable Digestive System Neuroendocrine Neoplasm; Metastatic Digestive System Neuroendocrine Neoplasm; Midgut Neuroendocrine Tumor; Pancreatic Neuroendocrine Tumor; Refractory Digestive System Neuroendocrine Neoplasm
University of Washington
2019-10-31 PHASE2
NCT02645149 COMPLETED
Melanoma
Melanoma Institute Australia
2021-11-22 PHASE2
NCT05759572 RECRUITING
Breast Cancer Metastatic
Fudan University
2023-02-01 PHASE2
NCT05759546 RECRUITING
Breast Cancer Metastatic
Fudan University
2023-02-01 PHASE2
NCT06613373 NOT_YET_RECRUITING
Breast Cancer
Jiangsu Famous Medical Technology Co., Ltd.
2024-10-15 PHASE4
NCT07130097 COMPLETED
Healthy Participant
Pfizer
2025-08-14 PHASE1
NCT07487129 COMPLETED
Breast Cancer
Beni-Suef University
2024-08-25 PHASE4
NCT06572800 COMPLETED
Anatomic Stage IV Breast Cancer AJCC v8; Metastatic HER2-Negative Breast Carcinoma
Yale University
2023-09-05
NCT06206837 ACTIVE_NOT_RECRUITING
Breast Cancer
Pfizer
2024-02-19 PHASE1; PHASE2
NCT06465368 COMPLETED
Breast Cancer
Pfizer
2024-07-11 PHASE2
NCT04125277 ACTIVE_NOT_RECRUITING
Breast Cancer
The Netherlands Cancer Institute
2019-12-05
NCT04964934 ACTIVE_NOT_RECRUITING
ER-Positive HER2-Negative Breast Cancer
AstraZeneca
2021-06-30 PHASE3
NCT04650581 ACTIVE_NOT_RECRUITING
Breast Cancer
Canadian Cancer Trials Group
2021-01-27 PHASE3
NCT06897683 COMPLETED
Healthy Adults
Pfizer
2025-03-21 PHASE1
NCT05335473 UNKNOWN
HR Positive HER2 Negative Advanced Breast Cancer
Henan Cancer Hospital
2022-05-13 PHASE1; PHASE2
NCT05865132 UNKNOWN
Esophagus Squamous Cell Carcinoma
AIPING ZHOU
2023-04-06 PHASE2
NCT05809024 UNKNOWN
Locally Advanced Breast Cancer; Hormone Receptor Positive,HER2-negative Breast Cancer
Yongsheng Wang
2023-03-01 PHASE4
NCT05806671 UNKNOWN
Breast Cancer
Tianjin Medical University Cancer Institute and Hospital
2023-05 PHASE2
NCT06133088 UNKNOWN
Advanced HR-positive and HER2-negative Breast Cancer; CDK4/6 Inhibitor Treatment Failed
Zhejiang Cancer Hospital
2023-08-01 PHASE2
NCT06243185 UNKNOWN
Recurrent Ovarian Carcinoma
Fengzhi Feng
2023-11-17 PHASE2
NCT05303129 COMPLETED
Breast Cancer; Metastatic Breast Cancer
Centre Francois Baclesse
2022-05-27
NCT05580588 TERMINATED
Liposarcoma, Dedifferentiated
Shanghai Pharma Biotherapeutics USA Inc.
2023-08-31 PHASE2
NCT03242382 UNKNOWN
Soft-tissue Sarcoma; Osteosarcoma; Chordoma
Grupo Espanol de Investigacion en Sarcomas
2017-03-31 PHASE2
NCT04594005 COMPLETED
Tumors
Yonsei University
2021-02-25 PHASE1; PHASE2
NCT03837821 ACTIVE_NOT_RECRUITING
Bladder Cancer
Weill Medical College of Cornell University
2019-02-05 EARLY_PHASE1
NCT05923411 COMPLETED
Healthy Participants
Pfizer
2023-07-11 PHASE1
NCT05953350 RECRUITING
Inhibition of Autophagy Synergizes Anti-tumor Effect
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2023-11-07 PHASE1; PHASE2
NCT05806047 UNKNOWN
Hormone Receptor-positive Advanced Breast Cancer
Fudan University
2023-05-01 PHASE2
NCT06267963 COMPLETED
Healthy Participants
Pfizer
2024-01-31 PHASE1
NCT04251169 TERMINATED
Metastatic Breast Cancer
SOLTI Breast Cancer Research Group
2020-07-21 PHASE2
NCT05411380 UNKNOWN
Breast Cancer
wang shusen
2022-10-03 PHASE2
NCT05079360 WITHDRAWN
Metastatic Breast Cancer
Veru Inc.
2023-03-15 PHASE2
NCT04315233 TERMINATED
Metastatic Breast Cancer; Recurrent Ovarian Carcinoma
University of Utah
2021-05-03 PHASE1
NCT03024489 UNKNOWN
Head and Neck Cancer; Locally Advanced
Mahidol University
2017-07-19 PHASE1; PHASE2
NCT05429684 UNKNOWN
HER2+ Breast Cancer
First Affiliated Hospital Xi'an Jiaotong University
2021-01-01 PHASE3
NCT05169567 ACTIVE_NOT_RECRUITING
Breast Neoplasm; Neoplasm Metastasis
Eli Lilly and Company
2022-03-11 PHASE3
NCT06206837 Recruiting
Breast Cancer
Pfizer|Arvinas Estrogen Receptor Inc.
2024-02-19 Phase 1|Phase 2
NCT04869943 TERMINATED
Metastatic Breast Cancer
Veru Inc.
2021-10-12 PHASE3
NCT05295043 UNKNOWN
Advanced HR+ HER2 Negative Breast Carcinoma
Tianjin Medical University Cancer Institute and Hospital
2022-12-10
NCT04494958 COMPLETED
Triple Negative Breast Cancer
Fundacion Oncosur
2020-11-18 PHASE1; PHASE2
NCT03854903 COMPLETED
Metastatic Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Hormone Receptor Positive Breast Cancer
Georgetown University
2019-04-01 PHASE1
NCT04074785 TERMINATED
GBM; Glioblastoma; Brain Tumor; Brain Tumor, Recurrent
University of Texas Southwestern Medical Center
2019-12-13 EARLY_PHASE1
NCT05670054 UNKNOWN
Breast Cancer Stage IV
Mansoura University
2022-03-01 PHASE3
NCT05139082 UNKNOWN
Digestive System Tumors
Peking University
2021-11-24 PHASE1; PHASE2
NCT05808582 UNKNOWN
Hormone Receptor-positive Advanced Breast Cancer
The First Affiliated Hospital with Nanjing Medical University
2023-05-01 PHASE2
NCT05512780 UNKNOWN
Solid Tumor
Hebei Medical University Fourth Hospital
2022-09-10 PHASE2
NCT04318223 UNKNOWN
Metastatic Breast Cancer; Locally Advanced Breast Cancer
Consorzio Oncotech
2019-07-16 PHASE2
NCT04391595 COMPLETED
Glioblastoma; GBM; Glioma
Nader Sanai
2020-07-11 EARLY_PHASE1
NCT04738292 TERMINATED
ER-positive Breast Cancer; HER2-negative Breast Cancer; Metastatic Cancer
University of Wisconsin, Madison
2021-10-05 PHASE2
NCT03425838 ACTIVE_NOT_RECRUITING
Breast Neoplasm Female
Borstkanker Onderzoek Groep
2017-11-09 PHASE3
NCT03170206 COMPLETED
Lung Cancer
Dana-Farber Cancer Institute
2017-05-31 PHASE1
NCT04707196 COMPLETED
Breast Neoplasms; Neoplasm Metastasis
Eli Lilly and Company
2021-02-22 PHASE4
NCT03959891 ACTIVE_NOT_RECRUITING
Breast Cancer
Massachusetts General Hospital
2019-05-30 PHASE1
NCT03110744 COMPLETED
Chordoma
University Hospital Heidelberg
2017-12-15 PHASE2
NCT03805399 UNKNOWN
Triple-negative Breast Cancer
Fudan University
2018-10-18 PHASE1; PHASE2
NCT05371275 WITHDRAWN
COVID-19
biotx.ai GmbH
2022-04-21 PHASE2
NCT04733417 UNKNOWN
Advanced Breast Cancer; Metastatic Breast Cancer
Tianjin Medical University Cancer Institute and Hospital
2021-05-26 PHASE2
NCT05191914 UNKNOWN
Breast Cancer
Liaoning Cancer Hospital & Institute
2022-02-07 PHASE4
NCT03555877 COMPLETED
Breast Cancer Metastatic
GBG Forschungs GmbH
2018-03-15 PHASE2
NCT03237390 COMPLETED
Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm
Mayo Clinic
2018-01-04 PHASE1
NCT02905318 ACTIVE_NOT_RECRUITING
Prostate Cancer
Canadian Cancer Trials Group
2017-07-04 PHASE2
NCT03988114 WITHDRAWN
Metastatic Breast Cancer
Eli Lilly and Company
2019-09-16 PHASE4
NCT03905889 TERMINATED
Renal Cell Carcinoma Metastatic
Brown University
2019-06-05 PHASE1
NCT03803761 WITHDRAWN
Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Metastatic Malignant Neoplasm in the Brain; Prognostic Stage IV Breast Cancer AJCC v8
National Cancer Institute (NCI)
2019-02-13 PHASE1; PHASE2
NCT03227328 COMPLETED
Hormone Receptor Positive Breast Cancer; Metastatic Breast Cancer; Hormone Receptor Negative Breast Cancer
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
2017-08-02 PHASE2
NCT06390839 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm
National Cancer Institute (NCI)
2017-03-22 PHASE2
NCT04095390 UNKNOWN
Metastatic Breast Cancer; HER2-positive Breast Cancer
Jinming Yu
2019-09-30 PHASE2
NCT03965845 COMPLETED
Solid Tumors; NSCLC; CRC; KRAS Gene Mutation
Calithera Biosciences, Inc
2019-06-25 PHASE1; PHASE2
NCT04615312 UNKNOWN
Digestive System Tumors
Henan Cancer Hospital
2020-11-14 PHASE1
NCT03778931 COMPLETED
Breast Cancer
Stemline Therapeutics, Inc.
2019-05-10 PHASE3
NCT04293276 UNKNOWN
Metastatic Breast Cancer
Henan Cancer Hospital
2020-04-01 PHASE2
NCT03981614 COMPLETED
Metastatic Colorectal Carcinoma; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Unresectable Carcinoma
Academic and Community Cancer Research United
2019-10-29 PHASE2
NCT02494921 COMPLETED
Prostate Cancer
Rahul Aggarwal
2015-11-20 PHASE1; PHASE2
NCT03792256 COMPLETED
Leukemia, Lymphocytic; Lymphoblastic Lymphoma; T-cell Lymphoma; T-cell Leukemia; Recurrent Disease; Acute Leukemia
Children's Oncology Group
2019-04-11 PHASE1
NCT03238196 COMPLETED
Metastatic Breast Cancer
Vanderbilt-Ingram Cancer Center
2017-08-18 PHASE1
NCT01723774 ACTIVE_NOT_RECRUITING
Breast Neoplasms
Washington University School of Medicine
2013-04-10 PHASE2
NCT03447132 COMPLETED
Breast Neoplasm Female
International Cancer Research Group, United Arab Emirates
2017-12-20 PHASE3
NCT04162301 TERMINATED
Advanced Solid Tumor
CStone Pharmaceuticals
2019-12-30 PHASE1
NCT01522989 UNKNOWN
Advanced Solid Tumor Malignancies
Georgetown University
2011-12 PHASE1
NCT03993964 UNKNOWN
Metastatic Breast Cancer
Sun Yat-sen University
2019-08-15 PHASE2
NCT03294694 TERMINATED
Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer; HER2-Negative Breast Cancer; Metastatic Epithelial Ovarian Cancer
Dana-Farber Cancer Institute
2017-11-08 PHASE1
NCT04274933 TERMINATED
Breast Cancer; Cancer
AbbVie
2020-05-21 PHASE1
NCT02297438 COMPLETED
Breast Neoplasms
Pfizer
2015-03-23 PHASE3
NCT02657343 COMPLETED
Breast Cancer
Dana-Farber Cancer Institute
2016-03-09 PHASE1; PHASE2
NCT01864746 COMPLETED
Breast Cancer; Hormonreceptor Positive; Her2-normal; Postneoadjuvant Treatment With CDK 4/6 Inhibitor; CPS-EG Score
GBG Forschungs GmbH
2013-10-30 PHASE3
NCT04031885 TERMINATED
Metastatic Breast Cancer
Eli Lilly and Company
2019-08-14 PHASE4
NCT03584009 TERMINATED
Estrogen Receptor-positive (ER+)/Human Epidermal Growth Factor Receptor (HER2)-Negative Locally Advanced or Metastatic Breast Cancer
Hoffmann-La Roche
2018-09-06 PHASE2
NCT03195192 COMPLETED
Metastatic Breast Cancer
Side-Out Foundation
2017-03-09
NCT03955939 COMPLETED
Metastatic Breast Cancer
Eli Lilly and Company
2019-08-02 PHASE1
NCT02732119 COMPLETED
Breast Cancer
Novartis Pharmaceuticals
2016-06-14 PHASE1; PHASE2
NCT02530320 COMPLETED
Oligodendroglioma; Oligoastrocytoma
Grupo Español de Investigación en Neurooncología
2015-10-25 PHASE2
NCT02345824 UNKNOWN
Glioblastoma; Glioma
University of Virginia
2016-03 PHASE1
NCT03601598 UNKNOWN
CRC; HCC; NSCLC
Harbin Medical University
2018-07-30 PHASE1; PHASE2
NCT02763566 ACTIVE_NOT_RECRUITING
Breast Cancer
Eli Lilly and Company
2016-12-05 PHASE3
NCT03050398 TERMINATED
Breast Cancer
Novartis Pharmaceuticals
2017-06-07 PHASE3
NCT02255461 TERMINATED
Childhood Choroid Plexus Tumor; Childhood Ependymoblastoma; Childhood Grade III Meningioma; Childhood High-grade Cerebellar Astrocytoma; Childhood High-grade Cerebral Astrocytoma; Childhood Medulloepithelioma; Recurrent Childhood Anaplastic Astrocytoma; Recurrent Childhood Anaplastic Oligoastrocytoma; Recurrent Childhood Anaplastic Oligodendroglioma; Recurrent Childhood Brain Stem Glioma; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Giant Cell Glioblastoma; Recurrent Childhood Glioblastoma; Recurrent Childhood Gliomatosis Cerebri; Recurrent Childhood Gliosarcoma; Recurrent Childhood Medulloblastoma; Recurrent Childhood Pineoblastoma; Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
Pediatric Brain Tumor Consortium
2014-12-08 PHASE1
NCT02501902 COMPLETED
Metastatic Pancreatic Ductal Adenocarcinoma
Pfizer
2015-11-23 PHASE1
NCT02292550 COMPLETED
Non-small Cell Lung Cancer
Novartis Pharmaceuticals
2015-05-14 PHASE1
NCT02499146 COMPLETED
Advanced Breast Cancer
Pfizer
2015-09-11 PHASE1
NCT02607124 TERMINATED
High Grade Glioma; Diffuse Intrinsic Pontine Glioma; Bithalamic High Grade Glioma
Children's Hospital Medical Center, Cincinnati
2016-04 PHASE1; PHASE2
NCT02187783 COMPLETED
Tumors With CDK4/6 Pathway Activation
Novartis Pharmaceuticals
2014-08-25 PHASE2
NCT02022982 COMPLETED
KRAS Mutant Non-Small Cell Lung Cancer; Solid Tumors
Dana-Farber Cancer Institute
2014-01 PHASE1
NCT02107703 ACTIVE_NOT_RECRUITING
Breast Neoplasms
Eli Lilly and Company
2014-07-22 PHASE3
NCT02549430 COMPLETED
Breast Cancer
Fondazione Sandro Pitigliani
2012-10 PHASE2
NCT02246621 ACTIVE_NOT_RECRUITING
Breast Cancer
Eli Lilly and Company
2014-11-06 PHASE3
NCT02821624 COMPLETED
Healthy Volunteers
G1 Therapeutics, Inc.
2016-05 PHASE1
NCT02065063 COMPLETED
Cancer
GlaxoSmithKline
2014-04-22 PHASE1
NCT02414724 TERMINATED
Lymphoma; Solid Neoplasm
Roswell Park Cancer Institute
2015-05 PHASE1
NCT01684215 COMPLETED
Neoplasms; Breast Neoplasms
Pfizer
2012-10-19 PHASE2
NCT01740427 COMPLETED
Breast Neoplasms
Pfizer
2013-02-22 PHASE3
NCT01739309 COMPLETED
Mantle Cell Lymphoma
Eli Lilly and Company
2013-03-20 PHASE2
NCT02243150 COMPLETED
Healthy Volunteers
G1 Therapeutics, Inc.
2014-09 PHASE1
NCT01394016 COMPLETED
Advanced Cancer
Eli Lilly and Company
2009-12-07 PHASE1
NCT01291017 COMPLETED
Non-small Cell Lung Cancer
University of Florida
2011-02 PHASE2
NCT00721409 COMPLETED
Breast Cancer
Pfizer
2008-09-15 PHASE2
NCT01709370 UNKNOWN
ER Positive, HER2 Negative Breast Cancer
Organisation for Oncology and Translational Research
2012-02 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the PF-07220060 (CDK4/6-IN-6) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-07220060 (atirmociclib) is a potent inhibitor targeting cyclin-dependent kinase 4 (CDK4/Cyclin D1, Ki = 0.6 nM) and cyclin-dependent kinase 6 (CDK6/Cyclin D3, Ki = 13.9 nM), thereby preventing retinoblastoma protein phosphorylation and blocking downstream cell cycle progression from the G1 to S phase. This targeted inhibition leads to sustained cell cycle arrest and suppression of cellular proliferation, providing therapeutic relevance for treating CDK4/6-dependent malignancies such as advanced or ER-positive HER2-negative breast cancer and solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.