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A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01823835
Recruitment Status : Terminated (The Sponsor decided to halt the development of GDC-0810, but not due to any safety concerns.)
First Posted : April 4, 2013
Results First Posted : June 18, 2021
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This study is a multi-institution, Phase Ia/Ib/IIa open-label, dose-finding, safety, pharmacokinetics (PK), and proof-of-concept study of GDC-0810 as a single agent and in combination with palbociclib and/or LHRH agonist. The study is divided into 3 phases: Phase Ia, Phase Ib, and Phase IIa. During Phase Ia (dose escalation phase), GDC-0810 single agent will be administered orally on a continuous daily dosing regimen with a Day -7 lead-in period for single dose PK evaluation prior to the start of daily treatment. The incidence of dose-limiting toxicities (DLTs) will be evaluated from Day -7 through the first cycle (28 days) of treatment (35 days total). Depending on safety and tolerability, participants will be assigned sequentially to escalating doses of GDC-0810 using standard 3 + 3 design. During Phase Ib (dose escalation and expansion phase), participants will receive GDC-0810 with palbociclib and/or LHRH agonist to determine the recommended Phase II dose (RP2D) and assess the safety and tolerability of concomitant administration. During Phase IIa (dose expansion phase), participants previously treated with an aromatase inhibitor (AI) will be treated at the RP2D to further characterize the safety, PK, pharmacodynamics, and anti-tumor activity of GDC-0810.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: GDC-0810 Drug: LHRH Agonist Drug: Palbociclib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase Ia/Ib/IIa Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or an LHRH Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
Actual Study Start Date : December 29, 2014
Actual Primary Completion Date : March 13, 2020
Actual Study Completion Date : March 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Phase Ia - Cohort 1
100 mg GDC-0810 once daily (QD) in fasting state.
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Experimental: Phase Ia - Cohort 2
200 mg GDC-0810 QD in fasting state.
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Experimental: Phase Ia - Cohort 3
400 mg GDC-0810 QD in fasting state.
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Experimental: Phase Ia - Cohort 4
600 mg GDC-0810 QD in fasting state.
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Experimental: Phase Ia - Cohort 5
600 mg GDC-0810 QD in non-fasting state.
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Experimental: Phase Ia - Cohort 6
300 mg GDC-0810 twice daily (BID) in fasting state.
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Experimental: Phase Ia - Cohort 7
800 mg GDC-0810 QD in fasting state.
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Experimental: Phase Ia - Cohort 8
800 mg GDC-0810 QD in non-fasting state.
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Experimental: Phase Ia - Cohort 9
400 mg GDC-0810 BID in fasting state.
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Experimental: Phase IIa - Cohort A1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had confirmed ER-a (ESR1) mutation of the ligand binding domain (LBD).
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Experimental: Phase IIa - Cohort A2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and confirmed ER-a (ESR1) mutation of the LBD.
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Experimental: Phase IIa - Cohort B1
600 mg GDC-0810 QD. Additionally, participants in this arm did not receive any prior treatment with fulvestrant and had progressed following ≤1 prior therapy with an aromatase inhibitor (AI).
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Experimental: Phase IIa - Cohort B2
600 mg GDC-0810 QD. Additionally, participants in this arm had prior treatment with fulvestrant and progressed following ≤1 prior therapy with an AI.
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Experimental: Phase Ib - Cohort C1
400 mg GDC-0810 + 125 mg Palbociclib QD.
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Drug: Palbociclib
Palbociclib administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Experimental: Phase Ib - Cohort D1
≤600 mg GDC-0810 QD + LHRH agonist once monthly.
Drug: GDC-0810
GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).

Drug: LHRH Agonist
LHRH agonist administered once monthly until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years). Choice of LHRH agonist will be an institutional choice approved for use in breast cancer.




Primary Outcome Measures :
  1. Phase Ia: Maximum Tolerated Dose of GDC-0810 When Used as a Single Agent [ Time Frame: Day -7 through the first cycle (28 days) of treatment (35 days total) ]

    Maximum Tolerated Dose (MTD) is determined based on the number of Dose Limiting Toxicities (DLTs) experienced by the participants. DLTs were defined as any of the following adverse events (AEs) that are deemed by the investigator or the Sponsor to be related to study drug (toxicities will be attributed to single agent GDC-0810 unless they are clearly related to disease progression or can clearly be attributed to a cause other than GDC-0810 administration):

    • Any grade ≥ 3 non-hematologic toxicity (excluding alopecia)
    • Any grade ≥ 3 hematologic toxicity of > 7 days' duration
    • Any grade toxicity that leads to study drug interruption of > 7 days' duration

  2. Phase Ia: RP2D of GDC-0810 When Used as a Single Agent [ Time Frame: Day -7 through the first cycle (28 days) of treatment (35 days total) ]
    The recommended Phase II dose (RP2D) was based on the overall safety/tolerability and pharmacokinetic profile of GDC-0810.

  3. Phase IIa: Percentage of Participants With Confirmed Objective Tumor Response of GDC-0810 According to RECIST v1.1 [ Time Frame: Screening and every 8 weeks from Cycle 1 Day 1 until Cycle 12, thereafter every 3 months until disease progression (up to 3 years) ]
    Objective response (OR) is defined as a complete response (CR) or partial response (PR) as determined by investigator assessment according to RECIST v1.1. OR was based on criteria related to changes in size of target lesions. CR was the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

  4. Phase IIa: Percentage of Participants With Clinical Benefit Response of GDC-0810 According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Screening and every 8 weeks from Cycle 1 Day 1 until Cycle 12, thereafter every 3 months until disease progression (up to 3 years) ]
    Clinical Benefit Response (CBR) is defined as the percentage of participants achieving confirmed RECIST v1.1 defined CR, PR, and/or stable disease. CR was the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.

  5. Phase Ib: RP2D of GDC-0810 When Used in Combination With Palbociclib and/or LHRH [ Time Frame: first cycle (Days 1 to 28 of a 28-day schedule) ]
    The RP2D of GDC-0810 When Used in Combination With Palbociclib and/or LHRH RP2D was not determined since the development of the GDC-0810 was discontinued before enrolling Cohort C2. The RP2D would have been based on the overall safety and PK/PD profile of GDC-0810 and palbociclib, and not necessarily the MTD.


Secondary Outcome Measures :
  1. All Phases: Percentage of Participants With Adverse Events (AEs) [ Time Frame: up to 3 years ]
    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.

  2. Phase Ia: Maximum Plasma Concentration (Cmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites [ Time Frame: Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, hours postdose ]
    Maximum Plasma Concentration (Cmax) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.

  3. Phase Ia: Time to Maximum Concentration (Tmax) of GDC-0810 Single Agent and Its Glucuronide Metabolites [ Time Frame: Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, hours postdose ]
    Time to Maximum Concentration (Tmax) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.

  4. Phase Ia: Area Under the Concentration-time Curves at 6 Hours (AUC0-6) of GDC-0810 Single Agent and Its Glucuronide Metabolites [ Time Frame: Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6 hours postdose ]
    Area under the concentration-time curves from time 0 to 6 hours (AUC0-6) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.

  5. Phase Ia: Area Under the Concentration-time Curves at 24 Hours (AUC0-24) of GDC-0810 Single Agent and Its Glucuronide Metabolites [ Time Frame: Single Dose: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours postdose; Multiple Doses: Day 29 (Cycle 2 Day 1) at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours postdose ]
    Area under the concentration-time curves from time 0 to 24 hours (AUC0-24) has been calculated using PK samples collected after administration of a single dose (on Day -7) and also following once-daily multiple doses (at steady state on Day 29) of GDC-0810.

  6. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) [ Time Frame: Day-7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours postdose ]
    Area under the concentration-time curve from time 0-infinity (AUC0-inf) has been calculated using PK samples collected after administration of a single dose (on Day -7) of GDC-0810.

  7. Phase Ia: Plasma Half-life (t1/2) of GDC-0810 Single Agent [ Time Frame: Day -7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdose ]
    Half-life (t1/2) was calculated after single dose administration and not at steady state.

  8. Phase Ia: Apparent Clearance (Cl/F) [ Time Frame: Day -7 at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours postdose ]
    Apparent Clearance (CL/F) was estimated using PK samples collected following administration of a single dose (on Day -7) of GDC-0810

  9. Phase IIa: Effect of GDC-0810 Single Agent on Ventricular Repolarization as Measured by Corrected QT Intervals (QTc) Using Fridericia's Formula [ Time Frame: Screening; on Cycle 2 Day 1 predose and at 1, 2, 3, 4, and 6 hours postdose; Cycle 3 Day 1 predose, and at 1, 3, and 6 hours post dose ]
    The corrected QT interval (QTc) was calculated using Fridericia's formula from electrocardiogram (ECG) data. Changes in ECG intervals from baseline were calculated. Triplicate ECG measurements were collected throughout the study. The averaged triplicate ECG measurements were used for analysis.

  10. Phase Ib: Cmax of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist [ Time Frame: C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1 ]
    Cmax has been calculated using PK samples collected after GDC-0810 administration.

  11. Phase Ib: Tmax of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist [ Time Frame: C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1 ]
    Tmax has been calculated using PK samples collected after GDC-0810 administration.

  12. Phase Ib: AUC0-6 of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist [ Time Frame: C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1 ]
    AUC0-6 has been calculated using PK samples collected after GDC-0810 administration.

  13. Phase Ib: t/2 of GDC-0810 in Combination With Palbociclib and/or an LHRH Agonist [ Time Frame: C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8; D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1 ]
    Half-life (t1/2) can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. The PK samples in these cohorts were only collected up to 6 hours following the dose, hence, t1/2 could not be estimated.

  14. Phase Ib: Cmax of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist [ Time Frame: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8 ]
    Cmax has been calculated using PK samples collected after GDC-0810 administration.

  15. Phase Ib: Tmax of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist [ Time Frame: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8 ]
    Tmax has been calculated using PK samples collected after GDC-0810 administration.

  16. Phase Ib: AUC0-6 of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist [ Time Frame: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8 ]
    AUC0-6 has been calculated using PK samples collected after GDC-0810 administration.

  17. Phase Ib: t/2 of Palbociclib in Combination With GDC-0810 and/or an LHRH Agonist [ Time Frame: Cohort C1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 8 ]
    Half-life (t1/2) can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. The PK samples in these cohorts were only collected up to 6 hours following the dose, hence, t1/2 could not be estimated.

  18. Phase Ib: Cmax of LHRH Agonist in Combination With GDC-0810 and/or Palbociclib [ Time Frame: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1 ]
    Cmax has been calculated using PK samples collected after GDC-0810 administration.

  19. Phase Ib: Tmax of LHRH Agonist in Combination With GDC-0810 and/or Palbociclib [ Time Frame: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1 ]
    Tmax has been calculated using PK samples collected after GDC-0810 administration.

  20. Phase Ib: AUC0-6 of LHRH Agonist in Combination With GDC-0810 and/or an Palbociclib [ Time Frame: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1 ]
    AUC0-6 has been calculated using PK samples collected after GDC-0810 administration.

  21. Phase Ib: t/2 of LHRH Agonist in Combination With GDC-0810 and/or Palbociclib [ Time Frame: Cohort D1: Predose and at 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1 ]
    Half-life (t1/2) can be estimated only when the PK sample collection following a dose is long enough to characterize the elimination phase. The PK samples in these cohorts were only collected up to 6 hours following the dose, hence, t1/2 could not be estimated.



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.


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

Inclusion Criteria:

Phase 1a portion

  • 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 metastatic disease, both progressing after at least 6 months of hormonal therapy for estrogen receptor (ER) positive breast cancer
  • ER-positive, human epidermal growth factor 2 (HER2) negative
  • At least 2 months must have elapsed from the use of tamoxifen
  • At least 6 months must have elapsed from the use of fulvestrant
  • At least 2 weeks must have elapsed from the use of any other anticancer hormonal therapy
  • At least 3 weeks must have elapsed from the use of any chemotherapy
  • Postmenopausal status
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  • Adequate organ function

Phase Ib portion

  • All above inclusion criteria, except:
  • Postmenopausal status, pre- and peri-menopausal participants will also be included
  • ECOG performance status less than 2
  • At least 2 months must have elapsed from the use of tamoxifen not applicable
  • At least 6 months must have elapsed from the use of fulvestrant not applicable

and plus:

  • Documented sensitivity to prior hormonal therapy
  • Cohort C1 (palbociclib combination cohorts): no prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitor

Phase IIa portion

  • All above inclusion criteria for Phase Ia, except:
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • At least 6 months must have elapsed from the use of fulvestrant not applicable

and plus:

  • Cohort A only: confirmed estrogen receptor alpha (ESR1) mutation and presence of measurable disease as per RECIST v1.1 or evaluable bone disease
  • Cohort A1 only: no prior fulvestrant allowed; at least 2 months must have elapsed from the use of tamoxifen
  • Cohort A2 only: prior fulvestrant allowed
  • Cohort B only: disease progression following no more than 1 prior treatment with an aromatase inhibitor in the advanced/metastatic setting
  • Cohort B1 only: no prior fulvestrant allowed
  • Cohort B2 only: prior fulvestrant allowed

Exclusion Criteria:

Phase 1a portion

  • Untreated or symptomatic central nervous system (CNS) metastases
  • Endometrial disorders
  • More than 2 prior chemotherapy in the advanced/metastatic setting (prior adjuvant chemotherapy is allowed so long as it occurred greater than or equal to 12 months prior to enrollment)
  • Current treatment with any systemic anticancer therapies for advanced disease
  • Any significant cardiac dysfunction within 12 months prior to enrollment
  • Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection
  • Known human immunodeficiency virus (HIV) infection
  • Known clinically significant history of liver disease
  • Major surgery within 4 weeks prior to enrollment
  • Radiation therapy within 2 weeks prior to enrollment

Phase Ib portion - all above exclusion criteria, plus:

  • Cohort C1 (palbociclib combination cohorts): history of venous thromboembolic event requiring therapeutic anticoagulation; vaginal bleeding within 2 months prior to enrollment

Phase IIa portion - all above exclusion criteria, plus:

  • Cohort A1, A2, and Cohort B2 only: more than 1 prior chemotherapy in the advanced/metastatic setting
  • Cohort B1 only: prior chemotherapy in the advanced/metastatic setting

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): NCT01823835


Locations
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United States, California
Ucsd Medical Center
San Diego, California, United States, 92103-8465
United States, Massachusetts
Massachusetts General Hospital.
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63128
United States, New York
Mount SInai Medical Center
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Netherlands
VU MEDISCH CENTRUM; Dept. of Medical Oncology
Amsterdam, Netherlands, 1081 HV
Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
Madrid, Spain, 28050
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Genentech, Inc.:
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01823835    
Other Study ID Numbers: GO29642
2014-004852-77 ( EudraCT Number )
First Posted: April 4, 2013    Key Record Dates
Results First Posted: June 18, 2021
Last Update Posted: June 18, 2021
Last Verified: May 2021

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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
Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action