NCT04802759 · Hoffmann-La Roche
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
What this study is about
This is a Phase Ib/II, where both patients and doctors know the treatment given, conducted at multiple hospitals, randomly assigned umbrella study in participants with breast cancer.
View original scientific description
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population.
Interventions
DRUG
Giredestrant
30 milligrams (mg) orally once a day (during each 28-day cycle or 21-day cycle, depending on the regimen) until unacceptable toxicity or disease progression
DRUG
Abemaciclib
150 mg orally twice a day (during each 28-day cycle or 21-day cycle, depending on the regimen) until unacceptable toxicity or disease progression
DRUG
Ipatasertib
400 mg orally once a day on Days 1-21 of each 28-day cycle until unacceptable toxicity or disease progression
DRUG
Inavolisib
9 mg orally once a day during each 28-day cycle until unacceptable toxicity or disease progression
DRUG
Ribociclib
600 mg orally once a day on Days 1-21 of each 28-day cycle until unacceptable toxicity or disease progression
DRUG
Everolimus
10 mg orally once a day during each 28-day cycle until unacceptable toxicity or disease progression
DRUG
Samuraciclib
360 mg orally once a day during each 28-day cycle until unacceptable toxicity or disease progression
DRUG
PH FDC SC
On Day 1 of Cycle 1 (1 cycle is 21 days), pertuzumab and trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) will be administered SC as a fixed dose formulation of 1200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase. On Day 1 of Cycles 2 and beyond, PH FDC SC will be administered SC once every 21 days as a fixed dose of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase.
DRUG
Palbociclib
125 mg orally once a day on Days 1-21 during each 28-day cycle until unacceptable toxicity or disease progression
DRUG
Atezolizumab
840 mg by intravenous (IV) infusion on Days 1 and 15 each 28-day cycle.
Primary outcome measures
Percentage of Participants with Objective Response, Defined as a Complete or Partial Response, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
Time frame: From Baseline until disease progression (up to 6 years)
Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
Time frame: From Baseline until 30 days after the last dose of study drug (up to 6 years)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Documented estrogen receptor-positive (ER+) tumor
- Patients for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
- Radiologic/objective evidence of recurrence or progression after the most recent systemic therapy for breast cancer
- Disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease (note: at least one line of therapy must have contained a CDK4/6i administered for a minimum of 8 weeks prior to disease progression.)
- Postmenopausal status for women
- Life expectancy ≥3 months
- Availability of a representative tumor specimen that is suitable for biomarker evaluation via central testing
- Prior fulvestrant therapy is all
Where
- Duarte, California
- Irvine, California
- San Francisco, California
- Santa Monica, California
- Stanford, California
- Boston, Massachusetts
- Freehold, New Jersey
- Howell Township, New Jersey
- Charlotte, North Carolina
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Germantown, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations