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Erlotinib Plus Chemotherapy for Treatment of Triple Negative Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erlotinib with neoadjuvant chemotherapy
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast, cancer, breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

erlotinib with neoadjuvant chemotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Pathological complete response rate (pCR)

Secondary Outcome Measures

Estimation of change in ki-67 (proliferation) after 2 cycles of neoadjuvant carboplatin/docetaxel based chemotherapy
Estimation of change in ki-67 after 2 cycles of carboplatin/docetaxel based neoadjuvant chemotherapy plus erlotinib
Assessment of toxicity of the combination of carboplatin/docetaxel chemotherapy plus erlotinib
Assessment of tolerability of 12 months of maintenance erlotinib treatment

Full Information

First Posted
June 22, 2007
Last Updated
January 18, 2017
Sponsor
University of Kansas Medical Center
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00491816
Brief Title
Erlotinib Plus Chemotherapy for Treatment of Triple Negative Breast Cancer
Official Title
Phase II Trial of Neoadjuvant Erlotinib Plus Chemotherapy for Treatment of ER Negative, PgR Negative and HER-2 Negative Primary Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast, cancer, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
erlotinib with neoadjuvant chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Erlotinib with neoadjuvant chemotherapy
Other Intervention Name(s)
Tarceva
Intervention Description
150 mg orally (PO) once daily on days 3 to 14, given with cycle 1 to 6 or 3 to 6 of neoadjuvant chemotherapy
Primary Outcome Measure Information:
Title
Pathological complete response rate (pCR)
Time Frame
After 18 weeks of neoadjuvant therapy
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Assessment of toxicity of the combination of carboplatin/docetaxel chemotherapy plus erlotinib
Time Frame
During neoadjuvant chemotherapy
Title
Assessment of tolerability of 12 months of maintenance erlotinib treatment
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priyanka Sharma, M.D.
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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Erlotinib Plus Chemotherapy for Treatment of Triple Negative Breast Cancer

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