ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
A 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 28 days, 90 days
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Screening period (up to 28 days); 2."
- "Safety follow-up (FU) period (for up to 90 days after administration of the last dose of trial treatment) and survival follow-up (until the participant dies, withdraws consent for survival status follow-up, loss of contact, or sponsor decision, whichever occurs first)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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.
Study sites (71)
AR
- Highlands Oncology Group · Springdale, AR 72762More trials in Springdale
CA
- University Of California - San Diego Moores Cancer Center · La Jolla, CA 92037More trials in La Jolla
- Cancer and Blood Specialty Clinic (CBSC) · Los Alamitos, CA 90720-3309More trials in Los Alamitos
- Cedar Sinai - Samuel Oschin Cancer Center · Los Angeles, CA 90048More trials in Los Angeles
- Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center · Palo Alto, CA 94304-2201More trials in Palo Alto
- University Of California Davis Health System · Sacramento, CA 95817-2229More trials in Sacramento
- Sansum Clinic · Santa Barbara, CA 93105More trials in Santa Barbara
- Saint John's Health Center - John Wayne Cancer Institute (JWCI) · Santa Monica, CA 90404-2312More trials in Santa Monica
FL
- Florida Cancer Specialists · Fort Myers, FL 33916More trials in Fort Myers
- Cancer Care Centers of Brevard, Inc · Palm Bay, FL 32901More trials in Palm Bay
- Sacred Heart Medical Oncology Group · Pensacola, FL 32504More trials in Pensacola
- Florida Cancer Specialists North · St. Petersburg, FL 33701More trials in St. Petersburg
IL
- Cancer Care Specialists · Decatur, IL 62526More trials in Decatur
- Cancer Care Specialists of Illinois · O'Fallon, IL 62269More trials in O'Fallon
- Carle Foundation Hospital d/b/a Carle Cancer Center · Urbana, IL 61801More trials in Urbana
KY
- University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center · Louisville, KY 40202More trials in Louisville
MA
- Lahey Hospital & Medical Center · Burlington, MA 01805More trials in Burlington
MD
- Saint Agnes Hospital, Clinical Research Center · Baltimore, MD 21229More trials in Baltimore
- Maryland Oncology Hematology P.A. · Columbia, MD 21044More trials in Columbia
ME
- New England Cancer Specialists · Westbrook, ME 04092More trials in Westbrook
MI
- Karmanos Cancer Center · Detroit, MI 48201More trials in Detroit
- Profound Research LLC at Michigan Hematology and Oncology Consultants · Royal Oak, MI 48073More trials in Royal Oak
MN
- Healthpartners Regions Specialty Clinics · Saint Louis Park, MN 55426More trials in Saint Louis Park
- Healthpartners Regions Specialty Clinics · Saint Paul, MN 55101-2502More trials in Saint Paul
MO
- Saint Luke's Hospital of Kansas City · Kansas City, MO 64111More trials in Kansas City
NC
- Oncology Specialists of Charlotte Pa · Charlotte, NC 28204More trials in Charlotte
- Carolina Oncology Specialists · Charlotte, NC 28210More trials in Charlotte
NE
- Oncology Hematology West, PC dba Nebraska Cancer Specialist · Grand Island, NE 68803More trials in Grand Island
- Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists · Omaha, NE 68310More trials in Omaha
NJ
- Summit Medical Group PA · Florham Park, NJ 07932More trials in Florham Park
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) · Livingston, NJ 07039More trials in Livingston
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) · Long Branch, NJ 07740More trials in Long Branch
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) · New Brunswick, NJ 08901More trials in New Brunswick
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) · Newark, NJ 07112More trials in Newark
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) · Somerville, NJ 08876More trials in Somerville
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) · Toms River, NJ 08755More trials in Toms River
NY
- Paradigm New York Cancer and Blood Specialists · Bay Shore, NY 11706More trials in Bay Shore
- Paradigm New York Cancer and Blood Specialists · New York, NY 10028More trials in New York
- Paradigm New York Cancer and Blood Specialists · New York, NY 10469More trials in New York
- Paradigm New York Cancer and Blood Specialists · New York, NY 11042More trials in New York
- Paradigm New York Cancer and Blood Specialists · New York, NY 11210More trials in New York
- Paradigm New York Cancer and Blood Specialists · New York, NY 11702More trials in New York
- Paradigm New York Cancer and Blood Specialists · New York, NY 11772More trials in New York
- Paradigm New York Cancer and Blood Specialists · New York, NY 11776More trials in New York
- Paradigm New York Cancer and Blood Specialists · New York, NY 11901More trials in New York
- Rochester General Hospital Lipson Cancer Institute · Rochester, NY 14621More trials in Rochester
- Stony Brook University Medical Center · Stony Brook, NY 11794More trials in Stony Brook
- Montefiore Medical Center · The Bronx, NY 10461More trials in The Bronx
OR
- St Charles Bend Cancer Center · Bend, OR 97701More trials in Bend
- Providence Portland Medical Center · Portland, OR 97213More trials in Portland
- St. Charles Cancer Center - Redmond · Redmond, OR 97756More trials in Redmond
- Oregon Oncology Specialists · Salem, OR 97301More trials in Salem
TN
- The West Clinic, P.C. dba West Cancer Center · Germantown, TN 38002More trials in Germantown
- Tennessee Oncology · Nashville, TN 37203More trials in Nashville
TX
- OneR The Center For Cancer And Blood Disorders (Texas Cancer Care) · Arlington, TX 76104More trials in Arlington
- OneR The Center For Cancer And Blood Disorders (Texas Cancer Care) · Burleson, TX 76028More trials in Burleson
- UT Southwestern Medical Center at Redbird · Dallas, TX 75237More trials in Dallas
- University Of Texas Southwestern Medical Center · Dallas, TX 75390More trials in Dallas
- JPS Health Network - Trinity Springs Pavilion · Fort Worth, TX 76104More trials in Fort Worth
- OneR The Center For Cancer And Blood Disorders (Texas Cancer Care) · Fort Worth, TX 76104More trials in Fort Worth
- UT Southwestern Moncrief Cancer Institute · Fort Worth, TX 76104More trials in Fort Worth
- Oncology Consultants PA · Houston, TX 77024More trials in Houston
- Oncology Consultants PA · Houston, TX 77030More trials in Houston
- UT Southwestern Medical Center at Richardson/Plano · Richardson, TX 75080More trials in Richardson
- Renovatio Clinical - The Woodlands Research Center · The Woodlands, TX 77380More trials in The Woodlands
- OneR The Center For Cancer And Blood Disorders (Texas Cancer Care) · Weatherford, TX 76068More trials in Weatherford
VA
- Bon Secours Cancer Institute at Memorial Regional · Mechanicsville, VA 23116More trials in Mechanicsville
- Bon Secours St. Francis Medical Center · Midlothian, VA 23114More trials in Midlothian
- Bon Secours Cancer Institute at St. Mary's · Richmond, VA 23226More trials in Richmond
WA
- Northwest Medical Specialties, PLLC · Tacoma, WA 98405More trials in Tacoma
WI
- Medical College of Wisconsin · Milwaukee, WI 53226More trials in Milwaukee