Study on Adding Copanlisib to Eribulin for Treating Metastatic Triple Negative Breast Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04345913
This clinical trial is exploring whether combining the drug copanlisib with eribulin can improve treatment outcomes for patients with triple negative breast cancer that has spread to other parts of the body. The study aims to find the best dose and assess the effectiveness of this combination therapy.
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Program Overview
This study is testing a new treatment approach for patients with triple negative breast cancer that has spread beyond its original site. Researchers are investigating if adding copanlisib to the chemotherapy drug eribulin can better control the cancer. Copanlisib works by blocking certain enzymes that help cancer cells grow, while eribulin stops cancer cells from dividing and spreading. The study will determine the safest and most effective dose of copanlisib when used with eribulin and compare the outcomes to using eribulin alone.
Description
The study is divided into two phases. In Phase I, researchers will determine the safest dose of copanlisib when combined with eribulin for treating metastatic triple negative breast cancer. In Phase II, they will compare how well the combination works against eribulin alone in patients who have previously been treated with certain chemotherapy drugs.
Participants will be randomly assigned to receive either eribulin alone or eribulin with copanlisib. The treatment cycles repeat every 21 days unless the cancer progresses or side effects become unacceptable. Throughout the study, participants will undergo regular scans and biopsies to monitor the cancer's response to treatment.
The study also aims to understand how different genetic factors and biomarkers might influence treatment response. Researchers will analyze tumor samples and blood tests to explore these aspects.
After completing the study treatment, participants will be followed up every three months for up to three years to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have metastatic or inoperable triple negative breast cancer, meaning the cancer does not have estrogen, progesterone, or HER2 receptors.
- Must have previously received treatment with anthracycline and taxane chemotherapy drugs, unless not suitable.
- Must have had progression on at least one but no more than five prior chemotherapy treatments.
- Must provide a tumor sample for research purposes.
- Must be 18 years or older.
- Must have good overall health with specific blood counts and organ function within normal limits.
- Must not have uncontrolled diabetes or other serious health conditions.
- Women of childbearing potential must use effective contraception during the study and for one month after.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Cannot have received chemotherapy or radiation within three weeks before starting the study.
- Cannot have been treated with eribulin or similar drugs before.
- Cannot have significant heart problems or abnormal heart rhythms.
- Cannot have severe nerve damage or other serious medical conditions.
- Cannot be taking certain medications that interact with copanlisib.
- Cannot have active infections or other serious health issues.
- Cannot be pregnant or breastfeeding due to potential risks to the baby.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Smilow Cancer Hospital-Derby Care Center | 06418 | Derby | Connecticut |
| Smilow Cancer Hospital Care Center-Fairfield | 06824 | Fairfield | Connecticut |
| Smilow Cancer Hospital Care Center at Glastonbury | 06033 | Glastonbury | Connecticut |
| Smilow Cancer Hospital Care Center at Greenwich | 06830 | Greenwich | Connecticut |
| Smilow Cancer Hospital Care Center - Guilford | 06437 | Guilford | Connecticut |
| Smilow Cancer Hospital Care Center at Saint Francis | 06105 | Hartford | Connecticut |
| Yale University | 06520 | New Haven | Connecticut |
| Yale-New Haven Hospital North Haven Medical Center | 06473 | North Haven | Connecticut |
| Smilow Cancer Hospital Care Center at Long Ridge | 06902 | Stamford | Connecticut |
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