ROSETTA Breast‑01: The effects and safety of pumitamig in patients with triple‑negative breast cancer
Trial Details
This trial will assess the safety and efficacy of a new investigational trial drug called pumitamig (also known as BNT327, PM8002 or BMS986545) for those living with TNBC. For patients with recurring or metastatic TNBC, chemotherapy remains the first-line standard of care. However, chemotherapy alone may not always be effective.
Pumitamig is a bispecific antibody (this means it targets two proteins on the tumor cell surface), called PD-L1 and VEGF. Pumatimig is being studied to assess whether blocking these proteins may turn on the body’s immune response. By combining pumitamig with a standard of care chemotherapy treatment, researchers seek to prolong the life of patients living with TNBC. Trial participation may last for up to two-and-a-half years, as researchers learn about the disease outcome when pumitamig is included as part of treatment.
Pumitamig is an investigational trial drug, which means health authorities have not approved it for doctors to prescribe to people with TNBC. There is no guarantee that health authorities, like the U.S. Food and Drug Administration, will approve it.
Trial Participant Requirements
Trial participation may continue as long as trial staff believe the patient is benefiting from and tolerating the trial treatment. Trial patients may choose to withdraw from the trial at any time without giving a reason. If a trial patient chooses to leave the trial this will not effect their medical care or lose any medical benefits to which they are entitled. The clinical trial will be conducted across three periods:
- Before treatment (up to 1 month): Trial patients will visit the trial site for pre-screening, to ensure you are eligible to participate in the trial.
- During treatment (up to 2 years): Trial patients will have up to 4 trial visits each month, most visits lasting 3-5 hours.
- After treatment (at least 3 months): Trial staff will monitor the health and cancer of trial patients, beginning with 3 trial visits and then with phone calls every 3 months.
A patient who enrolls in this metastatic breast cancer clinical trial, will be assigned by equal chance to one of two courses of treatment. One treatment plan will include pumitamig, along with chemotherapy delivered via intravenous (IV) infusion. The other will include a placebo along with chemotherapy.
By joining clinical trials for breast cancer, trial patients can help researchers discover new treatments and further understanding of potential treatment options for people with triple-negative breast cancer. There is no cost to trial patients for trial medicine or any tests or procedures that are part of the TNBC clinical trial. Some standard tests or treatments that patients would usually receive for breast cancer may not be covered as part of the TNBC clinical trial however, these may be covered by medical insurance (if applicable, subject to local laws and policies). The medical staff overseeing the clinical trial for triple-negative breast cancer will discuss this topic with you during the pre-screening process.
Key Inclusion and Exclusion criteria
This trial is looking for participants who may qualify, based on their age, diagnosis, and overall health. For more information, please contact [email protected].
Key inclusion criteria:
To be eligible for this clinical trial for metastatic breast cancer, participants must:
- Be at least 18 years old
- Have locally recurrent inoperable or metastatic TNBC (or ER-low, HER2-negative breast cancer)
- Have a tumor that has tested negative for a protein called PD-L1
Key exclusion criteria:
Participants must not:
- Have received prior systemic anticancer therapy for advanced disease
- Have had other malignant tumors within the past two years (*exceptions apply)
- Be receiving corticosteroids or anticonvulsants
- 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.
- 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.
About Clinical Trials for Triple-Negative Breast Cancer
Triple-negative breast cancer (TNBC) is an aggressive, fast-spreading cancer that historically has fewer treatment options than other forms of breast cancer.
Clinical studies for breast cancer have found that patients with cancer that has advanced locally or metastasized (meaning the cancer has spread to other parts of the body) often have responses to chemotherapy that are not as effective as they could be. This can be the case for patients with PD-L1 negative or BRCA negative TNBC..
Given the limited therapeutic options for TNBC patients, triple-negative breast cancer clinical trials are exploring new treatments that might be paired with chemotherapy to increase the number of patients who respond to treatment, increase the length of time a patient responds to treatment and improve how many patients live after their cancer treatment.