Neo-Adjuvant Study in Triple Negative Breast Cancer Patients

NCT01097642 | Completed Phase 2 Results DMC

• 2 other identifiers: Pro000022430908-0265
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Ixabepilone and capecitabine combination has demonstrated to be an active regimen in patients with metastatic breast cancer after failing other treatments. Cetuximab is active against tumors expressing epidermal growth factor receptor w/demonstrated activity in head \& neck and colorectal tumors and may be effective in some breast cancers known to express EGFR. Study seeks to evaluate Ixabepilone alone or in combination with cetuximab as a an antitumor therapy w/randomization stratified by stage (T1N1-3M0 or T2-4 N0-3M0).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  The study's primary objective is to determine the pathologic complete response rate (pCR) (breast and axilla) of Ixabepilone versus Ixabepilone when combined with cetuximab in patients with invasive breast adenocarcinoma T1N1-N3M0 or T2-4 N0-3M0 disease who are triple negative and who are candidates for preoperative chemotherapy. The criteria used: "Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

  one year after treatment

Secondary Outcomes (2)

• Recurrence Free Survival (RFS)

  Median 3-year

• Safety and Toxicity of Both Treatment Regimens: Number of Participants With Adverse Events

  one year after last treatment dose

Study Arms (2)

Ixabepilone

ACTIVE COMPARATOR

Brand name is Ixempra ®; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.

Drug: Ixabepilone

Ixabepilone plus Cetuximab

EXPERIMENTAL

Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.

Drug: Cetuximab; Drug: Ixabepilone

Interventions

Cetuximab DRUG

Cetuximab will be given at 400mg/m\^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m\^2 IV over 60 minutes.

Also known as: Erbitux

Ixabepilone plus Cetuximab

Ixabepilone DRUG

Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.

Also known as: azaepothilone B

Ixabepilone; Ixabepilone plus Cetuximab

Eligibility Criteria

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

You may qualify if:

• Patients with histologic confirmation of invasive breast carcinoma.
• Patients must have intact primary tumor.
• Patients greater than or equal to 18 years.
• Patients should have T1N1-3M0 or T2-4 N0-3M0.
• Patients with bilateral breast cancer are eligible.
• Patients with second primary breast cancers are eligible.
• Patients should have a Karnofsky performance scale of greater than or equal to 70%.
• Patients must have clinically measurable disease to be treated in the neoadjuvant setting.
• Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of greater than or equal to 1500/mm\^3, and platelet count greater than or equal to 100000mm\^3.
• Patients must have adequate liver function with a bilirubin within normal laboratory values. Alkaline phosphatase and transaminases (ALT and AST) may be up to 1.5 x upper limit of normal (ULN) of the institution.
• Patients should have adequate renal function with creatinine levels within normal range.
• Patients should have a normal left ventricular ejection fraction (LVEF) of greater than or equal to 50%.
• Negative serum or urine pregnancy test for a woman of childbearing potential (WOCBP).
• WOCBP must use a reliable and appropriate contraceptive method during the study and six months after chemotherapy is completed. WOCBP are women who are not menopausal for 12 months or had no previous surgical sterilization.
• Patients must agree to have study biopsies.

You may not qualify if:

• Patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer.
• Her2Neu, ER and PR positive patients should be excluded.
• Patients with Inflammatory breast cancer (IBC) are excluded.
• Patients with an organ allograft or other history of immune compromise.
• Prior treatment with any investigational drug within the preceding 4 weeks.
• Chronic treatment with systemic steroids or another immunosuppressive agent.
• A Known history of HIV seropositivity.
• Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin defined as 1 mg a day).
• Other concurrent and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration).
• Patients with a pre-existing peripheral neuropathy.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

The Methodist Hospital Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cetuximab; ixabepilone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Jenny Chang
• Organization: The Methodist Hospital Research Institute

jcchang@houstonmethodist.org

713 441-0680

Study Officials

• Jenny Chang, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: April 1, 2010
• Study Start: October 10, 2008
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 22, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)