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Tests treatment safety and results for Breast Neoplasms
Official title ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
ClinicalTrials.gov ID: NCT07173751
What this study is testing
What is Pumitamig?
Pumitamig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast neoplasms.
Also referred to as BNT327, PM8002.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1...
- Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal growth factor receptor 2...
- 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...
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
You likely can't join if
- 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)...
- 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.
See the full eligibility 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%...
- 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...
- 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...
- 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...
- Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.
The study team makes the final eligibility decision.
Where it's taking place
- Springdale, Arkansas, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Pensacola, Florida, United States
- Decatur, Illinois, United States
- O'Fallon, Illinois, United States
- Urbana, Illinois, United States
- Louisville, Kentucky, United States
- Westbrook, Maine, United States
- Baltimore, Maryland, United States
- Burlington, Massachusetts, United States
- Detroit, Michigan, United States
- Royal Oak, Michigan, United States
- Kansas City, Missouri, United States
- Grand Island, Nebraska, United States
- Omaha, Nebraska, United States
- Florham Park, New Jersey, United States
- Livingston, New Jersey, United States
- Long Branch, New Jersey, United States
+ 105 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Springdale, Arkansas, United States; La Jolla, California, United States; Los Angeles, California, United States; Palo Alto, California, United States; Pensacola, Florida, United States; Decatur, Illinois, United States and 119 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.