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New immunotherapy cocktails aim to tackle Hard-to-Treat breast cancer

NCT ID NCT03280563

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tested several immunotherapy-based drug combinations in 144 people with advanced hormone receptor-positive, HER2-negative breast cancer that had worsened after initial treatment. Participants received atezolizumab (Tecentriq) along with other drugs like bevacizumab or fulvestrant. The goal was to see if these combinations could shrink tumors or slow disease progression. The trial is now complete, and results will help guide future treatment options.

What this could mean

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

Active substance
Atezolizumab (Tecentriq) plus other drugs like bevacizumab or fulvestrant
What this could lead to
If successful, this could provide new treatment options for people with advanced breast cancer that has stopped responding to standard therapies.
What could go wrong
This is an early-phase study with a small number of participants, so results may not apply to everyone. Immunotherapy can cause immune-related side effects.

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

144 people

The number who actually took part.

Started

Dec 2017

Finished

Sep 2024

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

Female participants only

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 for Both Stages: * Measurable disease per RECIST v1.1 * Adequate hematologic and end organ function * Disease progression during or after first- or second-line hormonal therapy with CDK4/6 inhibitor Inclusion Criteria for Stage 1: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Metastatic or inoperable, locally advanced, histologically or cytologically confirmed invasive HR-positive HER2-negative breast cancer * Recommended for endocrine therapy, and cytotoxic chemotherapy not indicated at study entry * Recurrence or progression following most recent systemic breast cancer therapy * Disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease * Postmenopausal according to protocol-defined criteria * Life expectancy \>3 months * Available tumor specimen for determination of PD-L1 status Inclusion Criteria for Stage 2: * ECOG performance status of 0-2 * Ability to initiate treatment within 3 months after disease progression or unacceptable toxicity on a Stage 1 regimen Exclusion Criteria for Both Stages: * Significant or uncontrolled comorbid disease as specified in the protocol * Uncontrolled tumor-related pain * Autoimmune disease except for stable/controlled hypothyroidism, Type 1 diabetes mellitus, or certain dermatologic conditions * Positive human immunodeficiency virus test * Active hepatitis B or C * Active tuberculosis * Severe infection within 4 weeks and/or antibiotics within 2 weeks prior to study treatment * Prior allogeneic stem cell or solid organ transplantation * History of malignancy other than breast cancer within 2 years prior to screening except those with negligible risk of metastasis/death * History of or known hypersensitivity to study drug or excipients * For patients entering Stage 2, recovery from all immunotherapy-related adverse events to Grade 1 or better or to baseline at the time of consent Exclusion Criteria for Stage 1: * Prior fulvestrant or cytotoxic chemotherapy for metastatic breast cancer, or certain other agents as specified in the protocol * Unresolved AEs from prior anti-cancer therapy * Eligibility only for the control arm * Prior treatment with inhibitors as specified in the protocol Exclusion Criteria for Stage 2: * Unacceptable toxicity with atezolizumab during Stage 1 * Uncontrolled cardiovascular disease or coagulation disorder, including use of anticoagulants as specified in the protocol * Significant abdominal or intestinal manifestations within 6 months prior to treatment * Grade 2 or higher proteinuria

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast neoplasms

Contacts and locations

Locations

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231, United States

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • National Cancer Center

    Gyeonggi-do, 10408, South Korea

  • Northwest Georgia Oncology Centers PC - Marietta

    Marietta, Georgia, 30060, United States

  • Providence Cancer Center

    Portland, Oregon, 97231, United States

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492, Israel

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Sheba Medical Center

    Ramat Gan, 5262100, Israel

  • Stanford Cancer Institute

    Stanford, California, 94305-5456, United States

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • UCSF Helen Diller Family CCC

    San Francisco, California, 94158, United States

  • UPMC Pinnacle Health System

    Harrisburg, Pennsylvania, 17102, United States

  • Univ of Pittsburgh Sch of Med

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • University of Ulsan College of Medicine - Asan Medical Center

    Seoul, 05505, South Korea

  • Wellness Oncology and Hematology - Main Office

    West Hills, California, 91307, United States

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