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

NCT00656669 | Completed Results DMC

• 1 other identifier: 0802-15/1011003564; IUCRO-0215
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Keywords

newly diagnosed breast cancer; neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy

  Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value.

  baseline through end of segment 1 (2 weeks)

Secondary Outcomes (3)

• Change in Interstitial Fluid Pressure (IFP) Induced by Paclitaxel Plus Sunitinib After Sunitinib Monotherapy

  end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy) (112 days)

• Pathological Complete Response (pCR) Rate for Patients Treated With Sunitinib/Paclitaxel Followed by AC as Neoadjuvant Therapy for Breast Cancer

  screening through surgery

• To Evaluate the Safety of Paclitaxel Plus Sunitinib When Given in Combination as Neoadjuvant Therapy

  end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy)

Study Arms (1)

1

EXPERIMENTAL

The study will be conducted in 3 sequential treatment segments.

Drug: sunitinib alone; Drug: sunitinib plus paclitaxel; Drug: doxorubicin and cyclophosphamide

Interventions

sunitinib alone DRUG

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

1

sunitinib plus paclitaxel 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.

1

doxorubicin and cyclophosphamide DRUG

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

1

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically-confirmed adenocarcinoma of the breast with operable or inoperable stage 1c (primary tumor \> 1.0 cm), II or III disease.
• Measurable disease by physical examinations or diagnostic breast imaging (mammography, ultrasonography or MR).
• Pre-treatment core or incisional biopsy. Patients may not have had definitive primary surgery.
• Male or female, 18 years of age or older.
• ECOG performance status 0 or 1.
• Adequate organ function as defined in the protocol.

You may not qualify if:

• 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.
• Metastatic (Stage IV) breast cancer
• Patients who have had only a pre-treatment fine needle aspiration (FNA) are excluded.
• Current therapeutic treatment on another clinical trial with an investigational agent.
• 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
• 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.
• Hypertension that cannot be controlled by medications.
• Current treatment with therapeutic doses of any anti-coagulant. Prophylactic use of anticoagulants is allowed.
• Known human immunodeficiency virus (HIV) infection.
• Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test prior to first day of study medication.
• 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.

Sponsors & Collaborators

• Indiana University: lead
• Pfizer: collaborator

Study Sites (1)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sunitinib; Paclitaxel; Doxorubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Dr. Kathy Miller
• Organization: IndianaU

317-944-0920

Study Officials

• Kathy Miller, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 11, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 23, 2023
• Results First Posted: August 12, 2014

Record last verified: 2023-05

Locations

US (1)