Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-06-30

Brief Summary

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This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally advanced and metastatic breast cancer. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose (MTD) in breast cancer patients. Once the MTD is confirmed, up to 25 patients with locally advanced or metastatic breast cancer will be enrolled into the Phase II portion of the trial to further evaluate the safety and efficacy of CR011-vcMMAE.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CR011-vcMMAE

administered as an intravenous infusion on Day 1 of a 21 day cycle.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Females with confirmed breast cancer
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
* Locally advanced or metastatic disease who have received at least two prior chemotherapeutic regimens for breast cancer, as follows:

* At least one regimen must have been for locally advanced or metastatic disease
* Subject must have received an anthracycline, a taxane, and capecitabine in any combination unless the subject was intolerant to or not a candidate for any of these agents
* Hormonal therapy, biologic therapy (such as trastuzumab or bevacizumab), or immunotherapy do not count as one of the 2 regimens
* Subjects with HER2/neu overexpressing tumors must have been treated with trastuzumab except in situations where the subject was intolerant to or not a candidate for trastuzumab
* Documented progressive disease within 6 months of the last regimen
* Adequate bone marrow, renal and liver function
* Signed informed consent

Exclusion Criteria

* Chemotherapy, radiation, hormonal therapy, or bevacizumab within two weeks, or trastuzumab or investigational therapy within three weeks before treatment start
* Neuropathy \> NCI-CTCAE Grade 1
* Active brain metastases.
* New York Heart Association class III or IV heart disease
* Unstable angina
* Uncontrolled arrhythmia
* A marked baseline prolongation of QT/QTc interval
* Pregnant or breast-feeding women, and women of childbearing age and potential who are not willing to use effective contraception

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No