Erlotinib Plus Chemotherapy for Treatment of Triple Negative Breast Cancer

Conditions

• Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Erlotinib with neoadjuvant chemotherapy — DRUG
  150 mg orally (PO) once daily on days 3 to 14, given with cycle 1 to 6 or 3 to 6 of neoadjuvant chemotherapy

Study Details

Primary Study Objective: To assess the pathological complete response rate (pCR) with 4-6 cycles of neoadjuvant chemotherapy plus erlotinib in patients with triple negative breast cancer.

Key Dates

First listed

Jun 26, 2007

Start date

Jul 31, 2007

Status verified

Jan 2017

Primary completion

Dec 31, 2014

Completion

Dec 31, 2017

Study Design

Enrollment

32 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: erlotinib with neoadjuvant chemotherapy
  Study drug, erlotinib, is administered along with neoadjuvant chemotherapy. Adjuvant therapy given at discretion of treating physician. Once adjuvant therapy is completed, all patients will receive erlotinib 150 mg daily for 1 year.

Primary Outcome Measure

Pathological complete response rate (pCR) [ Time Frame: After 18 weeks of neoadjuvant therapy ]

Locations (1)

Find similar trials in Kansas City, KS

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