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Hormone Therapy

GDC-9545 + Palbociclib/LHRH Agonist for Breast Cancer

Phase 1

Waitlist Available

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Measurable disease, or evaluable bone disease; that is, bone lesions that are lytic or mixed (lytic + sclerotic) in the absence of measurable lesion

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

Must not have

Major surgery within 4 weeks prior to enrollment

Radiation therapy within 2 weeks prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, cycle 1, and at each subsequent cycle (1 cycle is 28 days) or at every other cycle starting from cycle 3 (cohort x only), up to 28 days after the last dose of study treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of the drug GDC-9545 as a treatment for people with a certain type of breast cancer.

Who is the study for?

This trial is for postmenopausal women with advanced or metastatic ER-positive/HER2-negative breast cancer. Participants should have an ECOG Performance Status ≤1, no more than two prior treatments for their condition, and adequate organ function. They must not have had certain recent surgeries or therapies, severe medical conditions that could affect safety or results, known HIV infection, significant heart disease risks, untreated brain metastases, or a history of certain malignancies within the last three years.

What is being tested?

The study tests GDC-9545's effectiveness and safety alone and in combination with palbociclib and/or LHRH agonist in treating estrogen receptor-positive breast cancer. It will assess how the body processes these drugs (PK), their impact on the body (PD), and preliminary anti-tumor activity through various stages including dose escalation.

What are the potential side effects?

Potential side effects may include typical reactions to hormone therapies such as hot flashes, fatigue, joint pain; from palbociclib like low white blood cell counts leading to increased infection risk; gastrointestinal issues; possible liver function changes; and other common medication-related adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have cancer that can be measured or seen in my bones.

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My breast cancer has returned or spread and cannot be removed or cured with surgery or radiation.

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My breast cancer is HER2-negative.

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I am fully active or can carry out light work.

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My advanced cancer does not respond to or cannot tolerate standard treatments.

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I have had 2 or fewer treatments for advanced breast cancer.

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It's been over 2 months since I last used tamoxifen and over 6 months since I last used fulvestrant.

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I have gone through menopause.

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My tumor is estrogen receptor positive.

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I have not been treated with CDK4/6 inhibitors before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 4 weeks.

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I have not had radiation therapy in the last 2 weeks.

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I am HIV positive.

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I have brain metastases that are either untreated, causing symptoms, or need treatment for symptoms.

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I am currently taking warfarin or phenytoin.

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I have an active inflammatory bowel condition or have had major GI surgery.

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My heart's electrical activity, measured twice, shows a specific irregularity.

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I am currently taking medication that can affect my heart's rhythm.

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I have a history or risk of irregular heartbeats due to heart conditions or family history.

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I have a serious liver condition, such as hepatitis or cirrhosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, cycle 1, and at each subsequent cycle (1 cycle is 28 days) or at every other cycle starting from cycle 3 (cohort x only), up to 28 days after the last dose of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, cycle 1, and at each subsequent cycle (1 cycle is 28 days) or at every other cycle starting from cycle 3 (cohort x only), up to 28 days after the last dose of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, cycle 1, and at each subsequent cycle (1 cycle is 28 days) or at every other cycle starting from cycle 3 (cohort x only), up to 28 days after the last dose of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Clinical Laboratory Abnormalities in Blood Chemistry Tests by Highest Grade According to NCI-CTCAE v4.0

Number of Participants with Clinical Laboratory Abnormalities in Hematology Tests by Highest Grade According to NCI-CTCAE v4.0

Number of Participants with Clinical Laboratory Abnormalities in Urinalysis Tests by Highest Grade According to NCI-CTCAE v4.0

Secondary study objectives

Clinical Benefit Rate

Percentage of Participants with Objective Response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

12Treatment groups

Experimental Treatment

Group I: Dose Expansion: Cohort X: GDC-9545 Dose 3Experimental Treatment1 Intervention

GDC-9545 will be administered at a pre-defined dose level (Dose 3) to postmenopausal participants currently receiving clinical benefit with GDC-0927 or GDC-0810 on Studies GO29656 (NCT02316509) or GO29642 (NCT01823835), respectively, upon completion of their studies.

Group II: Dose Expansion: Cohort C2: GDC-9545 Dose 2 + PalbociclibExperimental Treatment2 Interventions

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.

Group III: Dose Expansion: Cohort C1: GDC-9545 Dose 2 +/- PalbociclibExperimental Treatment2 Interventions

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.

Group IV: Dose Expansion: Cohort B2: GDC-9545 + Palbociclib + LHRHExperimental Treatment3 Interventions

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.

Group V: Dose Expansion: Cohort B1: GDC-9545 + PalbociclibExperimental Treatment2 Interventions

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.

Group VI: Dose Expansion: Cohort A5: GDC-9545 Dose 3Experimental Treatment1 Intervention

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).

Group VII: Dose Expansion: Cohort A4: GDC-9545 Dose 2 + LHRHExperimental Treatment2 Interventions

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.

Group VIII: Dose Expansion: Cohort A3: GDC-9545 Dose 2Experimental Treatment1 Intervention

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).

Group IX: Dose Expansion: Cohort A2: GDC-9545 Dose 1 + LHRHExperimental Treatment2 Interventions

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.

Group X: Dose Expansion: Cohort A1: GDC-9545 Dose 1Experimental Treatment1 Intervention

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).

Group XI: Dose Escalation: GDC-9545Experimental Treatment1 Intervention

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).

Group XII: Dose Escalation: Cohort B0: GDC-9545 + PalbociclibExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palbociclib

2017

Completed Phase 3

~3880

LHRH Agonist

2013

Completed Phase 2

~130