EUCTR2015-002395-24-BE
Active, not recruiting
Phase 1
Phase II, Open-Label, Randomized, Controlled Study of PM060184 in Advanced, Hormone Receptor Positive, HER2 negative Breast Cancer Patients in Third or Fourth Line Setting.
Pharma Mar, S.A.0 sites106 target enrollmentMay 11, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Pharma Mar, S.A.
- Enrollment
- 106
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Voluntarily written informed consent (IC), obtained from the patient before the beginning of any specific study procedures.
- •2\) Age \= 18 years.
- •3\) Histologically proven diagnosis of breast cancer.
- •4\) Tumors must be hormone receptor (ER and/or PgR) positive and
- •HER2 negative.
- •5\) Two or three chemotherapy lines in the advanced setting (adjuvant and/or neoadjuvant chemotherapy are allowed).
- •6\) Previous treatment with anthracyclines and taxanes (unless clinically contraindicated for any of them).
- •7\) Disease progression should have occurred within 2 months before study entry and within 6 months of the last administration of chemotherapy for advanced disease.
- •8\) Measurable disease as defined by the RECIST criteria v.1\.1\. If the only tumor lesion is situated in a previously irradiated area, or in an area subjected to other loco\-regional therapy, progression of the lesion must be demonstrated.
- •9\) Patients with dermic metastatic pattern only: lesions should have at least 10 mm diameter assessed by calipers and should be documented by color photography including a ruler to estimate the size of the lesion.
Exclusion Criteria
- •1\) Prior exposure to PM060184\.
- •2\) Concomitant administration of any other antineoplastic therapy.
- •3\) History of another neoplastic disease (except for prior breast cancer,
- •basal cell carcinoma of the skin, properly treated in situ carcinoma of
- •the uterine cervix, or melanoma in situ), unless in remission for five
- •years or longer and without local or systemic recurrence.
- •4\) Presence of cerebral and/or leptomeningeal metastasis, even if they
- •are being treated.
- •5\) Patients with locally advanced disease amenable to local therapy at
- •study entry.
Outcomes
Primary Outcomes
Not specified
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