Evaluating treatment combinations for advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of various treatment combinations in patients with metastatic or locally advanced breast cancer. It consists of two stages, with four cohorts focusing on different patient populations based on their previous treatments and tumor characteristics. Participants will receive treatments such as Capecitabine, Atezolizumab, and others, depending on their cohort classification. The study aims to determine the best therapeutic strategies for these challenging cases of breast cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria

Patients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort):

* Age \>/= 18 years at the time of signing Informed Consent Form
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1
* Able to comply with the study protocol, in the investigator's judgment
* Metastatic or inoperable locally advanced adenocarcinoma of the breast
* Measurable disease (at least one target lesion) according to RECIST v1.1
* Life expectancy \>/= 3 months, as determined by the investigator
* Tumor accessible for biopsy, unless archival tissue is available
* Availability of a representative tumor specimen that is suitable for biomarker analysis via central testing
* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from breastfeeding and donating eggs, as outlined for each specific treatment arm
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm

Exclusion Criteria

Exclusion Criteria for Stage 1

* Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, CD40 agonists or interleukin-2 (IL-2) or IL-2-like compounds
* Biologic treatment (e.g., bevacizumab) within 2 weeks prior to initiation of study treatment, or other systemic treatment for TNBC within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
* Eligibility only for the control arm

Exclusion Criteria for Stage 1 (both cohorts) and Stage 2 (2L CIT-naïve cohort)

* Adverse events from prior anti-cancer therapy that have not resolved to Grade \</= 1 or better with the exception of alopecia of any grade and Grade \</= 2 peripheral neuropathy
* Treatment with investigational therapy within 28 days prior to initiation of study treatment
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
* Uncontrolled tumor-related pain
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* History of leptomeningeal disease
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
* Active tuberculosis
* Severe infection within 4 weeks prior to initiation of study treatment
* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
* Significant cardiovascular disease
* Prior allogeneic stem cell or solid organ transplantation
* History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study

Where it's running

• City of Hope - Duarte
  Duarte, California, United States Recruiting
• City of Hope - Orange County Lennar Foundation Cancer Center
  Irvine, California, United States Recruiting
• University of California San Diego (UCSD) - Koman Family Outpatient Pavilion ? La Jolla
  La Jolla, California, United States Recruiting
• UCLA Health 200 Medical Plaza
  Los Angeles, California, United States Recruiting
• City of Hope® Cancer Center Chicago
  Zion, Illinois, United States Recruiting
• Metro-Minnesota Community Oncology Research Consortium
  Saint Paul, Minnesota, United States Recruiting

+5 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: CO40115 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. and Canada)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.