Pumitamig plus chemotherapy for metastatic triple-negative 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 is a randomized, double-blind Phase 3 trial that assigns participants 1:1 to receive either pumitamig plus physician's choice chemotherapy or placebo plus the same chemotherapy. Chemotherapy options include paclitaxel/nab-paclitaxel, gemcitabine plus carboplatin, or eribulin and are given per standard of care until disease progression or unacceptable toxicity. Randomization is stratified by prior immunotherapy exposure, chosen chemotherapy regimen, geography (East Asia vs rest of world), and PD‑L1 combined positive score. Participants undergo screening, an on-treatment period, a 90-day safety follow-up after last dose, and long-term survival follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.
* Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER and/or progesterone receptor \[PgR\]) 1% to 10%, HER2 immunohistochemistry \[IHC\] 0, 1+, or 2+ with fluorescence in situ hybridization \[FISH\] negative for HER2 gene amplification) documented prior to trial screening as part of standard of care.
* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.
* Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable; participants with only one target lesion are not eligible to participate in the trial).
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Have received any of the following therapies or drugs prior to the initiation of trial:

  * Have received prior systemic anticancer therapy for advanced disease.
  * Have received prior treatment with a PD(L)-1/vascular endothelial growth factor (VEGF) bispecific antibody.
  * Have received systemic corticosteroids (at a dosage greater than 10 milligrams \[mg\]/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of trial treatment. Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\<= 7 days) of corticosteroids for prophylaxis (for example, prevention of contrast agent allergy) or treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by exposure to allergens).
  * Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment.
  * Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment.
* Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.
* Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial. Placement of vascular infusion devices is allowed.
* Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.

Where it's running

• Highlands Oncology Group
  Springdale, Arkansas, United States Recruiting
• University Of California - San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• Cancer and Blood Specialty Clinic (CBSC)
  Los Alamitos, California, United States Recruiting
• Cedar Sinai - Samuel Oschin Cancer Center
  Los Angeles, California, United States Recruiting
• Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
  Palo Alto, California, United States Recruiting
• University Of California Davis Health System
  Sacramento, California, United States Recruiting

+174 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BioNTech clinical trials patient information
• Email: patients@biontech.de
• Phone: +49 6131 9084

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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.