Phase IIa Open Label, Randomized Clinical Trial to Study Vintafolide and Paclitaxel in Subjects with Advanced Triple Negative Breast Cancer Using SPECT/CT scan with Etarfolatide (EC20) for Subject Selectio

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 102

Inclusion Criteria

- Female subjects must have histologically or cytologically confirmed ER-, PR-, HER2 – advanced breast cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- Have developed progressive disease following at least 1 (and not more than 4) prior chemotherapeutic regimens for breast cancer, which was administered for treatment of locally recurrent and/or metastatic disease
- At least 1 regimen must have included a taxane (e.g. paclitaxel or docetaxel) in any combination or order. Prior taxane may have been administered as adjuvant and/or neoadjuvant therapy.
- Subject is = 18 years of age on day of signing informed consent
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have at least a single (RECIST 1.1 defined) measurable lesion
- All tumor target lesions characterized as FR(100%) using etarfolatide screened assessed by central core facility.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 68
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

Has had chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to drug administration or who has not recovered (=Grade 1 or baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Is currently participating or has participated in a study with an investigational compound or device within 28 days of initial dosing on this study.
- Has received more than 4 prior cytotoxic regimens for metastatic disease.
- Has a primary central nervous system (CNS) tumor.
- Has active CNS metastases and/or carcinomatous meningitis. However, subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids or on a stable dose of steroids for at least 2 weeks.
- Has had prior therapy with vinorelbine (Navelbine®) or vinca-containing compounds.
- Has known hypersensitivity to the components of the study therapy or its analogs. This includes paclitaxel, docetaxel, other taxane therapies, drugs formulated with polyoxyethylated castor oil (Cremphor EL), vinlastine, or other vinca-derived therapies.
- Has pre-existing neuropathy > Grade 2. Subjects with residual drug-induced neuropathy of =2 will be eligible if it has stable, and not worsening, for at least 30 days.
- Has a bowel occlusion or subocclusion.
- Has had prior abdominal or pelvis radiation therapy or radiation therapy to > 10% of the bone marrow at any time in the past or prior radiation therapy within the last three years to the breast/sternum, dermal lesions, head, or neck.
- Requires anti-folate therapy for the management of co-morbid conditions (e.g., rheumatoid arthritis).
- Has symptomatic ascites or pleural effusion. A subject who is clinically stable following treatment for these conditions is eligible for the study however.
- Has had a prior stem cell or bone marrow transplant

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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