Evaluate the Benefit of Adding ART6043 to Olaparib for HER2-Negative Metastatic or Advanced Breast Cancer and a gBRCA Mutation (POLKA)
*Paid Promotion
Treatment
Metastatic breast cancer treatment study
Clinicaltrials.gov identifier:NCT05898399
Phase 1/2
Study Contact Information:
To help find a location near you, email [email protected]
About the Study
This study is evaluating the addition of ART6043, a novel , to , a standard treatment, in adults with advanced or breast cancer and an inherited gBRCA mutation. The study will compare ART6043 plus with alone to better understand the potential benefits and risks of treatment.
This Study is Open To:
- You are 18 years of age or older
- You have , locally advanced or breast cancer
- You have an inherited mutation.
- You have received less than 1 month’s treatment with a (such as )
- You have previously received treatment for your breast cancer and may be eligible for treatment with a and your cancer did not worsen while receiving previous treatment with a .
- You can provide a tumor tissue sample or are willing to undergo a tumor biopsy if needed for the study.
This Study is NOT Open To:
- You have significant heart disease or reduced heart function.
- You have active or uncontrolled brain .
- You have inflammatory breast cancer.
- You have myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or findings that may suggest MDS or AML.
- You have ongoing interstitial lung disease or pneumonitis.
What the Study Involves
This is a Phase 2, , .
People who join the study will:
- Have screening tests to see if they are eligible
- Be assigned to receive either the ART6043 plus the olaparib or alone.
- Take the study medicines as tablets twice a day in 21-day cycles.
- Have regular clinic visits for physical examinations, ECGs, and CT or scans.
- Provide a tumor tissue sample from a prior biopsy or have a tumor biopsy if enough stored tumor tissue is not available.
- Provide blood and urine samples during the study.
- Continue study treatment unless their cancer gets worse, they have side effects that are not acceptable, or they choose to stop participating in the study.
Participants may receive reimbursement for reasonable travel expenses incurred while on the study.
Lead Researchers/Study PIs and Affiliation
Mark Robson, Memorial Sloan Kettering
Study Contact Information:
To help find a location near you, email [email protected]
Locations:
Other Countries
Country: Spain
City: A Coruña RECRUITING
Facility: Complejo Hospitalario Universitario A Coruña CHUAC
Contact Info:
No contact info provided
Country: Spain
City: Bàguena RECRUITING
Facility: Instituto Valenciano de Oncologia-IVO
Contact Info:
No contact info provided
Country: Spain
City: Cadiz RECRUITING
Facility: Hospital Universitario de Jerez de la Frontera
Contact Info:
No contact info provided
Country: Spain
City: Canara RECRUITING
Facility: Hospital Universitario de Canarias
Contact Info:
No contact info provided
Country: Spain
City: Jaén RECRUITING
Facility: Hospital Universitario de Jaen
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: Hospital General Universitario Gregorio Marañon
Contact Info:
No contact info provided
Country: Spain
City: Málaga RECRUITING
Facility: Hospital Universitario Virgen de la Victoria
Contact Info:
No contact info provided
Country: Spain
City: Murcia RECRUITING
Facility: Hospital Clinico Universitario Virgen de la Arrixaca
Contact Info:
No contact info provided
Country: Spain
City: Seville RECRUITING
Facility: Hospital Universitario Virgen del Rocio
Contact Info:
No contact info provided
Country: Spain
City: Seville RECRUITING
Facility: Hospital Universitario Virgen Macarena
Contact Info:
No contact info provided
Country: Spain
City: Valencia RECRUITING
Facility: Hospital Clinico Universitario de Valencia
Contact Info:
No contact info provided
Country: Spain
City: Zaragoza RECRUITING
Facility: Hospital Clinico Universitario Lozano Blesa
Contact Info:
No contact info provided
Country: Spain
State: Andalusia
City: Granada RECRUITING
Facility: Hospital Universitario Clínico San Cecilio
Contact Info:
No contact info provided
Country: Spain
State: Castille and León
City: Valladolid RECRUITING
Facility: Hospital Clínico Universitario de Valladolid
Contact Info:
No contact info provided
Country: Spain
State: Catalonia
City: Barcelona RECRUITING
Facility: Hospital de la Santa Creu i Sant Pau
Contact Info:
No contact info provided
Country: Spain
State: Extremadura
City: Cáceres RECRUITING
Facility: Hospital San Pedro de Alcántara
Contact Info:
No contact info provided
Country: Spain
State: Madrid
City: Madrid RECRUITING
Facility: Hospital Universitario 12 de Octubre
Contact Info:
No contact info provided
Country: Spain
State: Madrid
City: San Carlos RECRUITING
Facility: Hospital Clinico San Carlos
Contact Info:
No contact info provided
Country: United Kingdom
City: London RECRUITING
Facility: University College London
Contact Info:
No contact info provided
Country: United Kingdom
City: Manchester RECRUITING
Facility: The Christie
Contact Info:
No contact info provided
*Note: FORCE has received funding to help enrollment efforts on this study.
Treatment
Metastatic breast cancer treatment study
Clinicaltrials.gov identifier:NCT05898399
Phase 1/2
Study Contact Information:
To help find a location near you, email [email protected]