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New umbrella study aims to match breast cancer patients with best drug cocktail

NCT ID NCT03424005

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 7 times

Summary

This study is testing many different drug combinations in people with metastatic breast cancer that has spread or cannot be removed by surgery. Researchers are looking at which combinations work best for different cancer types, such as triple-negative or hormone receptor-positive. The goal is to improve response rates and control the disease longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Capecitabine, Atezolizumab, and other drug combinations
What this could lead to
If successful, this could identify better treatment combinations for different types of metastatic breast cancer, potentially improving survival and quality of life.
What could go wrong
This is an early-phase (1b/2) study, so results are preliminary. Many combinations may not work better than current treatments, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 1,132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2018

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm HER2 positive breast carcinoma Her2-receptor negative breast cancer hormone receptor-positive breast cancer invasive breast carcinoma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    37 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Assuta Medical Centers

    RECRUITING

    Tel Aviv, 69710, Israel

  • Barts Health NHS Trust - St Bartholomew's Hospital

    COMPLETED

    London, EC1A 7BE, United Kingdom

  • Beatson West of Scotland Cancer Centre

    COMPLETED

    Glasgow, G12 0YN, United Kingdom

  • Centre Léon Bérard

    COMPLETED

    Lyon, 69008, France

  • Centro Integral Oncológico Clara Campal Ensayos Clínicos START

    RECRUITING

    Madrid, 28050, Spain

  • City of Hope

    COMPLETED

    Duarte, California, 91010, United States

  • City of Hope - Duarte

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope - Orange County Lennar Foundation Cancer Center

    RECRUITING

    Irvine, California, 92618, United States

  • City of Hope® Cancer Center Chicago

    RECRUITING

    Zion, Illinois, 60099, United States

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27710-2000, United States

  • Fiona Stanley Hospital - Medical Oncology

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • H. Lee Moffitt Cancer Center and Research Inst.

    COMPLETED

    Tampa, Florida, 33612, United States

  • Hackensack Univ Medical Center

    WITHDRAWN

    Hackensack, New Jersey, 07601, United States

  • Hadassah University Medical Center

    RECRUITING

    Jerusalem, 91120, Israel

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, Sevilla, 41009, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, 08003, Spain

  • Institut Universitaire du Cancer de Toulouse-Oncopole

    RECRUITING

    Toulouse, 31059, France

  • Institut régional du Cancer Montpellier

    WITHDRAWN

    Montpellier, 34298, France

  • Metro-Minnesota Community Oncology Research Consortium

    RECRUITING

    Saint Paul, Minnesota, 55101-2502, United States

  • NYU Langone Medical Center

    WITHDRAWN

    New York, New York, 10016, United States

  • National Cancer Center Clinical Trials Center / Center for Breast Cancer

    RECRUITING

    Goyang-si, 410-769, South Korea

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 704302, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • Peter MacCallum Cancer Centre-East Melbourne

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Rabin MC

    RECRUITING

    Petah Tikva, 55900, Israel

  • Rambam Medical Center

    RECRUITING

    Haifa, 3109601, Israel

  • Regional Cancer Care Associates, LLC

    WITHDRAWN

    Howell Township, New Jersey, 07731, United States

  • Renown Regional Medical Center

    RECRUITING

    Reno, Nevada, 89502-1576, United States

  • Rocky Mountain Cancer Center - Longmont

    COMPLETED

    Longmont, Colorado, 80501, United States

  • Rutgers Cancer Institute of New Jersey

    WITHDRAWN

    New Brunswick, New Jersey, 08901, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, 9103102, Israel

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 5262100, Israel

  • Stanford Cancer Institute

    WITHDRAWN

    Stanford, California, 94305, United States

  • Tel-Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Tennessee Oncology - Chattanooga Oncology & Hematology Associates

    RECRUITING

    Chattanooga, Tennessee, 37404, United States

  • Tennessee Oncology PLLC

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Oncology-Plano East

    WITHDRAWN

    Plano, Texas, 75075-7787, United States

  • The West Clinic

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • Thomas Jefferson University Hospital

    WITHDRAWN

    Philadelphia, Pennsylvania, 19107, United States

  • UCLA Health 200 Medical Plaza

    RECRUITING

    Los Angeles, California, 90004, United States

  • University of California San Diego (UCSD) - Koman Family Outpatient Pavilion ? La Jolla

    RECRUITING

    La Jolla, California, 92093-1350, United States

  • University of California San Diego Medical Center

    COMPLETED

    La Jolla, California, 92093, United States

  • University of Pittsburgh Medical Center

    WITHDRAWN

    Pittsburgh, Pennsylvania, 15213, United States

  • Universitätsklinikum Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Universitätsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    RECRUITING

    Barcelona, 08035, Spain

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37212, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.