Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer

NCT ID: NCT00656669

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-09-30

Brief Summary

The combination of paclitaxel, doxorubicin, and cyclophosphamide is a standard neoadjuvant (given before surgery) treatment for patients that have either inoperable or operable breast cancer. This treatment can help shrink the tumors so they can be removed to help prevent the cancer from spreading to other parts of the body. This study is being done to test the impact of adding sunitinib as a single-agent (Segment 1), followed by sunitinib plus paclitaxel (Segment 2), followed by doxorubicin and cyclophosphamide (Segment 3). We hope the addition of sunitinib will make the treatment more effective, but we don't know if this is true.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

The study will be conducted in 3 sequential treatment segments.

Group Type: EXPERIMENTAL

sunitinib alone

Intervention Type: DRUG

sunitinib alone (segment 1): During the first segment, patients will receive single-agent sunitinib for 2 weeks.

sunitinib plus paclitaxel

Intervention Type: DRUG

sunitinib plus paclitaxel (Segment 2): Following Segment 1, patients will begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.

doxorubicin and cyclophosphamide

Intervention Type: DRUG

doxorubicin and cyclophosphamide (Segment 3): Following Segment 2, patients will receive 4 cycles (8 weeks) of neoadjuvant treatment with AC.

Interventions

sunitinib alone

sunitinib alone (segment 1): During the first segment, patients will receive single-agent sunitinib for 2 weeks.

Intervention Type: DRUG

sunitinib plus paclitaxel

sunitinib plus paclitaxel (Segment 2): Following Segment 1, patients will begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.

Intervention Type: DRUG

doxorubicin and cyclophosphamide

doxorubicin and cyclophosphamide (Segment 3): Following Segment 2, patients will receive 4 cycles (8 weeks) of neoadjuvant treatment with AC.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients must have histologically-confirmed adenocarcinoma of the breast with operable or inoperable stage 1c (primary tumor > 1.0 cm), II or III disease.

2. Measurable disease by physical examinations or diagnostic breast imaging (mammography, ultrasonography or MR).

3. Pre-treatment core or incisional biopsy. Patients may not have had definitive primary surgery.

4. Male or female, 18 years of age or older.

5. ECOG performance status 0 or 1.

6. Adequate organ function as defined in the protocol.

Exclusion Criteria

1. Prior radiation therapy, cytotoxic therapy or systemic therapy for breast cancer. Prior use of tamoxifen or raloxifene as chemoprevention is allowed but must be discontinued prior to study entry.

2. Metastatic (Stage IV) breast cancer

3. Patients who have had only a pre-treatment fine needle aspiration (FNA) are excluded.

4. Current therapeutic treatment on another clinical trial with an investigational agent.

5. Any of the following within the 6 months prior to starting study treatment: -myocardial infarction -severe/unstable angina -coronary/peripheral artery bypass graft -congestive heart failure -cerebrovascular accident including transient ischemic attack -pulmonary embolus

6. Ongoing cardiac dysrhythmias of NCI CTCAE grade >=2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.

7. Hypertension that cannot be controlled by medications.

8. Current treatment with therapeutic doses of any anti-coagulant. Prophylactic use of anticoagulants is allowed.

9. Known human immunodeficiency virus (HIV) infection.

10. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test prior to first day of study medication.

11. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Kathy Miller

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathy Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

0802-15/1011003564; IUCRO-0215

Identifier Type: -

Identifier Source: org_study_id