NL-OMON54538
Recruiting
Not Applicable
FUnctional selection of advanced breast cancer patients for Talazoparib treatment Using the REpair Capacity (RECAP) test: The FUTURE trial - the FUTURE trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- breast carcinoma
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 78
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>\=18 years
- •WHO performance status 0\-2
- •Locally advanced breast cancer without curative intent or metastatic breast
- •\* The breast cancer must be either
- •o high grade (Bloom \& Richardson grade 3\) ER positive (\>10%) and HER2 negative
- •primary breast cancer, or
- •o triple negative (ER\<10%, PR\<10% and HER2 negative), or
- •o any Bloom \& Richardson grading and receptor status and also
- •\* at least one metastatic lesion must have a proven HRD phenotype based on a
- •RECAP test not treated with anticancer therapy thereafter or
Exclusion Criteria
- •Any psychological condition potentially hampering compliance with the study
- •Any treatment with investigational antitumor drugs within 28 days prior to
- •receiving the first dose of investigational treatment; or within 21 days for
- •standard chemotherapy; or within 14 days for weekly scheduled chemotherapeutic
- •regimens or endocrine therapy
- •Radiotherapy within the last four weeks prior to receiving the first dose of
- •investigational treatment; except 1 or 2 x 8 Gy for pain palliation, then seven
- •days interval after the last radiation should be maintained
- •Known persistent (\>4 weeks) \>\= Grade 2 toxicity from prior cancer therapy
- •(except for alopecia grade 2\)
Outcomes
Primary Outcomes
Not specified
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