Erlotinib Plus Chemotherapy for Treatment of Triple Negative Breast Cancer

NCT00491816 | Unknown Phase 2 DMC

• 1 other identifier: 10864
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast; cancer; breast cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR)

  After 18 weeks of neoadjuvant therapy

Secondary Outcomes (4)

• Estimation of change in ki-67 (proliferation) after 2 cycles of neoadjuvant carboplatin/docetaxel based chemotherapy

  After 2 cycles (6 weeks) of therapy

• Estimation of change in ki-67 after 2 cycles of carboplatin/docetaxel based neoadjuvant chemotherapy plus erlotinib

  After 2 cycles (6 weeks) of therapy

• Assessment of toxicity of the combination of carboplatin/docetaxel chemotherapy plus erlotinib

  During neoadjuvant chemotherapy

• Assessment of tolerability of 12 months of maintenance erlotinib treatment

  12 months

Study Arms (1)

erlotinib with neoadjuvant chemotherapy

EXPERIMENTAL

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.

Drug: Erlotinib with neoadjuvant chemotherapy

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

Also known as: Tarceva

erlotinib with neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient ≥ 18 years of age
• Histologically proven stage II or III adenocarcinoma of the breast
• Patients must be candidates for neoadjuvant treatment (tumor size \> 2 cm, T2, T3, T4 and/or clinical N1 or N2)
• Estrogen Receptor negative, Progesterone Receptor negative and HER-2 negative disease (IHC 0 or 1+ and/or FISH negative)
• Performance status of 2 or better
• No prior chemotherapy or endocrine therapy
• If female of childbearing potential, pregnancy test is negative and willing to use effective contraception while on treatment and for at least 3 months after the last dose of study drug
• Adequate bone marrow function: neutrophils ≥ 1500/mm3, platelet count ≥ 100,000/mm3, and hemoglobin ≥ 11 g/dL
• Adequate kidney function: serum creatinine ≤ 1.5 mg/dl and/or creatinine clearance of ≥ 60 mL/min
• Adequate hepatic function: transaminases \< 2 x upper limit of normal and total bilirubin ≤ 1.5 mg/dL
• Patients must have a serum albumin ≥ 3.0 g/dL
• Patients must have a Prothrombin Time, Partial Thromboplastin Time within normal limits
• Patients must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rules
• Pretreatment lab values must be performed within 14 days of patient registration, and other baseline studies within 30 days
• Patients will have a baseline mammogram, bone scan, CT chest and abdomen

You may not qualify if:

• Patients with metastatic disease are excluded from study
• The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications
• Pregnancy or lactation
• Prior use of an Epidermal growth factor receptor inhibitor
• Patients with a history of chronic pulmonary disease are excluded from study
• Patients with inadequate laboratory values (as defined above) are excluded from study
• Patients with NCI common toxicity criteria (CTC) grade 2 or greater peripheral neuropathy are excluded from study
• Patients with active infection are excluded from study
• Patients with concomitant or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, are excluded from study
• Patients with emotional limitations are excluded from study
• Patients with inflammatory breast cancer will be excluded

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Erlotinib Hydrochloride; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics

Study Officials

• Priyanka Sharma, M.D.

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: June 26, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2017
• Last Updated: January 19, 2017

Record last verified: 2017-01

Locations

US (1)