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A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT03332797
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with palbociclib and/or luteinizing hormone−releasing hormone (LHRH) agonist in participants with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 [HER2]-negative) breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: GDC-9545 Drug: Palbociclib Drug: LHRH Agonist Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ia/Ib, Multicenter, Open-Label, Dose Escalation, Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-9545 Alone or in Combination With Palbociclib and/or LHRH Agonist in Patients With Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Dose Escalation: GDC-9545
During dose escalation, postmenopausal participants will be assigned sequentially to escalating doses of GDC-9545, up to the maximum tolerated dose (MTD) or maximum administered dose (MAD).
Drug: GDC-9545
GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Other Name: RG6171

Experimental: Dose Escalation: Cohort B0: GDC-9545 + Palbociclib
GDC-9545 will be administered to postmenopausal participants, at a dose lower than the MTD or MAD determined in single-agent dose escalation, in combination with the label-recommended dose of palbociclib.
Drug: GDC-9545
GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Other Name: RG6171

Drug: Palbociclib
Palbociclib will be administered orally, once daily, at the label-recommended dose of 125 mg on Days 1-21 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Experimental: Dose Expansion: Cohort A1: GDC-9545 Dose 1
GDC-9545 will be administered to postmenopausal participants as a single-agent at a dose that is less than or equal to the MTD/MAD (Dose 1).
Drug: GDC-9545
GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Other Name: RG6171

Experimental: Dose Expansion: Cohort A2: GDC-9545 Dose 1 + LHRH
GDC-9545 will be administered to pre- or perimenopausal participants at a dose that is less than or equal to the MTD/MAD (Dose 1) in combination with an approved LHRH agonist.
Drug: GDC-9545
GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Other Name: RG6171

Drug: LHRH Agonist
The LHRH agonist will be administered by injection once every 4 weeks on Day 1 of each 28-day cycle, according to the label. The investigator will choose the appropriate LHRH agonist approved for use in breast cancer.

Experimental: Dose Expansion: Cohort A3: GDC-9545 Dose 2
GDC-9545 will be administered to postmenopausal participants as a single-agent at a dose that is less than or equal to the MTD/MAD (Dose 2).
Drug: GDC-9545
GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Other Name: RG6171

Experimental: Dose Expansion: Cohort A4: GDC-9545 Dose 2 + LHRH
GDC-9545 will be administered to pre- or perimenopausal participants at a dose that is less than or equal to the MTD/MAD (Dose 2) in combination with an LHRH agonist.
Drug: GDC-9545
GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Other Name: RG6171

Drug: LHRH Agonist
The LHRH agonist will be administered by injection once every 4 weeks on Day 1 of each 28-day cycle, according to the label. The investigator will choose the appropriate LHRH agonist approved for use in breast cancer.

Experimental: Dose Expansion: Cohort A5: GDC-9545 Dose 3
GDC-9545 will be administered to postmenopausal participants as a single-agent at a dose that is less than or equal to the MTD/MAD (Dose 3).
Drug: GDC-9545
GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Other Name: RG6171

Experimental: Dose Expansion: Cohort B1: GDC-9545 + Palbociclib
GDC-9545 will be administered to postmenopausal participants, at a dose that is less than or equal to the MTD/MAD, in combination with the label-recommended dose of palbociclib.
Drug: GDC-9545
GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Other Name: RG6171

Drug: Palbociclib
Palbociclib will be administered orally, once daily, at the label-recommended dose of 125 mg on Days 1-21 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Experimental: Dose Expansion: Cohort B2: GDC-9545 + Palbociclib + LHRH
GDC-9545 will be administered to pre- or perimenopausal participants, at a dose that is less than or equal to the MTD/MAD, in combination with the label-recommended dose of palbociclib and an approved LHRH agonist.
Drug: GDC-9545
GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Other Name: RG6171

Drug: Palbociclib
Palbociclib will be administered orally, once daily, at the label-recommended dose of 125 mg on Days 1-21 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Drug: LHRH Agonist
The LHRH agonist will be administered by injection once every 4 weeks on Day 1 of each 28-day cycle, according to the label. The investigator will choose the appropriate LHRH agonist approved for use in breast cancer.

Experimental: Dose Expansion: Cohort C1: GDC-9545 Dose 2 +/- Palbociclib
GDC-9545 will be administered to postmenopausal participants at a pre-defined dose level (Dose 2) as a single agent for 14 days, followed by treatment with either GDC-9545 (Dose 2) plus palbociclib or GDC-9545 (Dose 2) alone for the duration of the study, as determined by the investigator.
Drug: GDC-9545
GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Other Name: RG6171

Drug: Palbociclib
Palbociclib will be administered orally, once daily, at the label-recommended dose of 125 mg on Days 1-21 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Experimental: Dose Expansion: Cohort C2: GDC-9545 Dose 2 + Palbociclib
GDC-9545 will be administered to postmenopausal participants at a pre-defined dose level (Dose 2), in combination with the label-recommended dose of palbociclib.
Drug: GDC-9545
GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Other Name: RG6171

Drug: Palbociclib
Palbociclib will be administered orally, once daily, at the label-recommended dose of 125 mg on Days 1-21 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.




Primary Outcome Measures :
  1. Number of Participants with Adverse Events by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0) [ Time Frame: From Baseline until 28 days after the last dose of study treatment (up to 48 months) ]
  2. Dose Escalation: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of GDC-9545 When Administered as a Single Agent or in Combination with Palbociclib [ Time Frame: Days -7 to 28 of Cycle 1 ]
  3. Dose Escalation: Number of Participants with Dose-Limiting Toxicities When GDC-9545 is Administered as a Single Agent or in Combination with Palbociclib [ Time Frame: Days -7 to 28 of Cycle 1 ]
  4. Change from Baseline in Systolic Blood Pressure Over Time [ Time Frame: Baseline and at each treatment cycle (1 cycle is 28 days) through to 28 days after the last dose of study treatment ]
  5. Change from Baseline in Diastolic Blood Pressure Over Time [ Time Frame: Baseline and at each treatment cycle (1 cycle is 28 days) through to 28 days after the last dose of study treatment ]
  6. Change from Baseline in Body Temperature Over Time [ Time Frame: Baseline and at each treatment cycle (1 cycle is 28 days) through to 28 days after the last dose of study treatment ]
  7. Change from Baseline in Pulse Rate Over Time [ Time Frame: Baseline and at each treatment cycle (1 cycle is 28 days) through to 28 days after the last dose of study treatment ]
  8. Change from Baseline in Respiration Rate Over Time [ Time Frame: Baseline and at each treatment cycle (1 cycle is 28 days) through to 28 days after the last dose of study treatment ]
  9. Change from Baseline in Electrocardiogram (ECG) Results Over Time: Heart Rate [ Time Frame: Baseline and at predefined intervals from Cycle 1, Day -7 (Single-Agent Dose Escalation, A1-A5, and C2 only) or Cycle 1, Day 1 (B0, B1, and B2) and at each subsequent cycle (1 cycle is 28 days) through to the last dose of study treatment ]
  10. Change from Baseline in ECG Results Over Time: PR Duration [ Time Frame: Baseline and at predefined intervals from Cycle 1, Day -7 (Single-Agent Dose Escalation, A1-A5, and C2 only) or Cycle 1, Day 1 (B0, B1, and B2) and at each subsequent cycle (1 cycle is 28 days) through to the last dose of study treatment ]
  11. Change from Baseline in ECG Results Over Time: QRS Duration [ Time Frame: Baseline and at predefined intervals from Cycle 1, Day -7 (Single-Agent Dose Escalation, A1-A5, and C2 only) or Cycle 1, Day 1 (B0, B1, and B2) and at each subsequent cycle (1 cycle is 28 days) through to the last dose of study treatment ]
  12. Change from Baseline in ECG Results Over Time: QT Duration [ Time Frame: Baseline and at predefined intervals from Cycle 1, Day -7 (Single-Agent Dose Escalation, A1-A5, and C2 only) or Cycle 1, Day 1 (B0, B1, and B2) and at each subsequent cycle (1 cycle is 28 days) through to the last dose of study treatment ]
  13. Change from Baseline in ECG Results Over Time: QTcF Duration [ Time Frame: Baseline and at predefined intervals from Cycle 1, Day -7 (Single-Agent Dose Escalation, A1-A5, and C2 only) or Cycle 1, Day 1 (B0, B1, and B2) and at each subsequent cycle (1 cycle is 28 days) through to the last dose of study treatment ]
  14. Change from Baseline in ECG Results Over Time: RR Duration [ Time Frame: Baseline and at predefined intervals from Cycle 1, Day -7 (Single-Agent Dose Escalation, A1-A5, and C2 only) or Cycle 1, Day 1 (B0, B1, and B2) and at each subsequent cycle (1 cycle is 28 days) through to the last dose of study treatment ]
  15. Number of Participants with Grade ≥3 Adverse Events of Clinical Laboratory Test Abnormalities [ Time Frame: Baseline and at predefined intervals from Cycle 1, Day -7 (Single-Agent Dose Escalation, A1-A5, and C2 only) or Cycle 1, Day 1 (B0, B1, and B2) and at each subsequent cycle (1 cycle is 28 days) through to the last dose of study treatment ]
    Clinical laboratory tests will include standard hematology, chemistry, and urinalysis parameters. Abnormal clinical laboratory test results that are outside the normal ranges will be graded according to NCI-CTCAE v4.0.


Secondary Outcome Measures :
  1. Plasma Concentration of GDC-9545 Over Time [ Time Frame: At predefined intervals from Cycle 1, Day -7 (Single-Agent Dose Escalation and A1-A5 only) or Cycle 1, Day 1 (B0, B1, and B2) to Cycle 4, Day 1 (1 cycle is 28 days) and at study completion; Cycle 1, Days -7 or 8 (C1 only); Cycle 1, Day 8 (C2 only) ]
  2. Plasma Concentration of Palbociclib Over Time [ Time Frame: At predefined intervals from Cycle 1, Day 1 to Cycle 4, Day 1 (1 cycle is 28 days) and at study completion (B0, B1, and B2 only); Cycle 1, Day 8 (C2 only) ]
  3. Plasma Concentration of LHRH Over Time [ Time Frame: At predefined intervals from Cycle 1, Day 1 to Cycle 4, Day 1 (1 cycle is 28 days) and at study completion (B2 only) ]
  4. Percentage of Participants with Objective Response [ Time Frame: Baseline and every 8 weeks from Cycle 1, Day 1 until end of study treatment (up to 48 months) ]
    Objective response is defined as a complete response or partial response on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1).

  5. Clinical Benefit Rate [ Time Frame: Baseline and every 8 weeks from Cycle 1, Day 1 until end of study treatment (up to 48 months) ]
    Clinical benefit rate is defined as the percentage of participants achieving either of the following: confirmed complete response or partial response (as determined by the investigator according to RECIST v1.1); or the first occurrence of progressive disease after 24 weeks of study treatment.

  6. Duration of Response [ Time Frame: From the first occurrence of a documented objective response until first observation of disease progression or death from any cause on study, whichever occurs first (up to 48 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Dose Escalation:

  • Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent or with metastatic disease
  • Estrogen receptor (ER)-positive tumor
  • Human epidermal growth factor receptor 2 (HER2)-negative breast cancer as per local laboratory testing
  • Measurable disease, or evaluable bone disease; that is, bone lesions that are lytic or mixed (lytic + sclerotic) in the absence of measurable lesion
  • Required paired pre- and on-treatment tumor biopsies for participants with metastases that are safely accessible as determined by the investigator
  • Advanced or metastatic ER-positive/HER2-negative breast cancer that has recurred or progressed while being treated with adjuvant endocrine therapy for a duration of at least 24 months and/or endocrine therapy in the incurable, locally advanced, or metastatic setting and derived a clinical benefit from therapy (i.e., tumor response or stable disease for at least 6 months)
  • No more than 2 prior lines of treatment for advanced or metastatic breast cancer
  • Greater than or equal to (≥)2 weeks must have elapsed from the use of any other endocrine, targeted therapy or chemotherapy
  • Single-Agent Cohorts (only applies to Dose Escalation): Advanced or metastatic disease that is either refractory to or intolerant of existing standard therapy or for which no effective standard therapy that confers clinical benefit is available
  • Cohort B0: No prior treatment with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor
  • For participants undergoing 18F-fluoroestradiol-positron emission tomography (FES-PET) imaging additional restrictions on prior therapy include: ≥2 months must have elapsed from the use of tamoxifen; ≥6 months must have elapsed from the use of fulvestrant
  • Postmenopausal status
  • Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (≤)1
  • Resolution of all acute toxic effects of prior therapy or surgical procedures to baseline or Grade ≤1 (except alopecia or other toxicities not considered to be a safety risk for the patient)
  • Life expectancy of ≥12 weeks
  • Adequate organ function

Inclusion Criteria for Dose Expansion:

Same criteria as above for Dose Escalation, except for those that only apply to Dose Escalation, plus the following:

  • Required paired pre- and on-treatment tumor biopsies for participants in Cohorts A1−A5, B1, and B2 with metastases that are safely accessible as determined by the investigator
  • In South Korea: Must have received exactly 2 prior lines of treatment for advanced or metastatic breast cancer
  • In the rest of the world: No more than 1 prior line of treatment for advanced or metastatic breast cancer

Plus the following criteria:

  • Cohorts B1 and B2: No prior treatment with CDK4/6 inhibitor
  • Cohorts A1, A3, A5, B1, C1, and C2 only: Postmenopausal status
  • Cohorts A2, A4, and B2 only: Participants not defined as postmenopausal; Age less than (<)56 years who have medical menopause on LHRH agonist (on stable dose ≥4 weeks)
  • No prior treatment with an oral selective estrogen receptor degrader (SERD)
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use non-hormonal contraceptive methods with a failure rate of <1% per year during the treatment period and for 40 days after the last dose of GDC-9545, and agreement to refrain from donating eggs during this same period

Exclusion Criteria for Dose Escalation:

  • Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
  • Current treatment with any systemic anti-cancer therapies for advanced disease
  • Concurrent treatment with warfarin or phenytoin
  • Diagnosis of any secondary malignancy within 3 years prior to enrollment, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
  • Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery including gastric resection
  • Known human immunodeficiency virus (HIV) infection
  • Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (e.g., hepatitis B or hepatitis C virus), current alcohol abuse, or cirrhosis
  • Major surgery within 4 weeks prior to enrollment
  • Radiation therapy within 2 weeks prior to enrollment
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
  • Inability or unwillingness to swallow tablets or capsules (only applies to Dose Escalation)
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study (only applies to Dose Escalation)
  • History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction
  • QT interval corrected using Fridericia's formula (QTcF) greater than (>)470 milliseconds (ms) demonstrated by at least two ECGs >30 minutes apart
  • History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease coronary heart disease clinically significant electrolyte abnormalities or family history of sudden unexplained death or long QT syndrome
  • Current treatment with medications that are well known to prolong the QT interval

Exclusion Criteria for Dose Expansion:

Same criteria as above for Dose Escalation, except for those that only apply to Dose Escalation, plus the following criteria:

  • Pregnant, lactating, or breastfeeding
  • Additional exclusion criteria for Cohort B (Phase 1b cohort): History of venous thromboembolic event requiring therapeutic anticoagulation
  • Additional exclusion criteria for Cohorts C1 and C2 only: Current treatment with medications that are well known to decrease heart rate, including beta blockers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332797


Contacts
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Contact: Reference Study ID Number: GO39932 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
United States, Massachusetts
Massachusetts General Hospital. Recruiting
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Tennessee
Vanderbilt University Medical Center; Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Australia, New South Wales
St Vincent's Hospital Sydney Recruiting
Darlinghurst, New South Wales, Australia, 2010
Australia, Victoria
Cabrini Hospital Malvern Recruiting
Malvern, Victoria, Australia, 3144
Peter Maccallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Korea, Republic of
National Cancer Center; Medical Oncology Recruiting
Gyeonggi-do, Korea, Republic of, 410-769
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center - Oncology Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 6351
Spain
ICO L'Hospitalet; Servicio de oncologia medica Recruiting
L Hospitalet De Llobregat, Barcelona, Spain, 08908
Onkologikoa; Ensayos Clinicos Recruiting
Donostia, Guipuzcoa, Spain, 20014
Hospital Quiron Barcelona; Servicio de Oncologia Recruiting
Barcelona, Spain, 08024
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
MD Anderson Cancer Center Madrid - España; Servicio de Farmacia Recruiting
Madrid, Spain, 28033
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Hospital General Universitario Gregorio Maranon Recruiting
Madrid, Spain, 28040
Hospital Universitario HM Sanchinarro; South Texas Accelerated Research Therapeutics Recruiting
Madrid, Spain, 28050
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
United Kingdom
Barts Health NHS Trust Recruiting
London, United Kingdom, E1 2ES
The Royal Marsden NHS Foundation Trust; Oncology Recruiting
London, United Kingdom, SW3 6JJ
The Royal Marsden Hospital Recruiting
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03332797     History of Changes
Other Study ID Numbers: GO39932
2017-002083-41 ( EudraCT Number )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Palbociclib
Prolactin Release-Inhibiting Factors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action