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Erlotinib Plus Chemotherapy for Treatment of Triple Negative Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT00491816
First received: June 22, 2007
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: Erlotinib with neoadjuvant chemotherapy
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Neoadjuvant Erlotinib Plus Chemotherapy for Treatment of ER Negative, PgR Negative and HER-2 Negative Primary Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Pathological complete response rate (pCR) [ Time Frame: After 18 weeks of neoadjuvant therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Estimation of change in ki-67 (proliferation) after 2 cycles of neoadjuvant carboplatin/docetaxel based chemotherapy [ Time Frame: After 2 cycles (6 weeks) of therapy ] [ Designated as safety issue: Yes ]
  • Estimation of change in ki-67 after 2 cycles of carboplatin/docetaxel based neoadjuvant chemotherapy plus erlotinib [ Time Frame: After 2 cycles (6 weeks) of therapy ] [ Designated as safety issue: Yes ]
  • Assessment of toxicity of the combination of carboplatin/docetaxel chemotherapy plus erlotinib [ Time Frame: During neoadjuvant chemotherapy ] [ Designated as safety issue: Yes ]
  • Assessment of tolerability of 12 months of maintenance erlotinib treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: July 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Erlotinib with neoadjuvant chemotherapy
150 mg orally (PO) once daily on days 3 to 14, given with cycle 1 to 6 or 3 to 6 of neoadjuvant chemotherapy
Other Name: Tarceva

Detailed Description:

Twenty percent of women with breast cancer have triple negative breast cancer. The standard treatment for triple negative breast cancer is typically a combination of chemotherapy, surgery, +/- radiation therapy. When treated with standard therapy women with triple negative breast cancer have a worse long term outcomes as compared to women who do not have triple negative breast cancer. Triple negative breast cancer cells usually have a surface marker called EGFR (epidermal growth factor receptor). Women whose breast cancer cells have the EGFR surface marker have worse long term outcomes as compared to women whose tumors do not have the EGFR marker. Erlotinib (Tarceva) targets EGFR and is currently used for treatment of other cancers like lung and pancreas. This study will assess a combination of chemotherapy with erlotinib in women with triple negative breast cancer.

For breast cancer patients who receive chemotherapy first and then get surgery, long-term survival is longer for women who do not have any microscopic cancer at the time of surgery. The primary objective of this study is to assess whether a combination of chemotherapy and erlotinib will result in no evidence of microscopic disease (pCR) at the time of surgery in greater than 20% of enrolled subjects. After completing all chemotherapy, patients will also receive maintenance erlotinib for 12 months. This is given to study the tolerability of maintenance Erlotinib and also to evaluate if maintenance erlotinib will decrease the rate of tumor recurrence.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491816

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Genentech
Investigators
Principal Investigator: Priyanka Sharma, M.D. University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00491816     History of Changes
Other Study ID Numbers: 10864
Study First Received: June 22, 2007
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
breast
cancer
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013