ROSETTA Breast-01: Evaluating the drug BNT327 (also called pumitamig) or placebo when given with chemotherapy in people with locally recurrent, inoperable or metastatic triple negative breast cancer or ER-low, HER2-negative breast cancerA Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease

Exclusion

• 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.