Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Paclitaxel

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Albumin-Bound Paclitaxel

Sunitinib

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

The study will be conducted in 3 sequential treatment segments.

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

sunitinib alone

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.

sunitinib plus paclitaxel

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

doxorubicin and cyclophosphamide

Kathy Miller, MD

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.

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

An Exploratory Study of the Biological and Clinical Activity of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer

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.

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 2 (paclitaxel/sunitinib therapy through cycle 5) and end of segment 1 (sunitinib monotherapy) mean value.

This measure determines the number of patients who had Grade 3/4 Adverse Events that were related to treatment while the patient was on paclitaxel plus sunitinib.

Pfizer

Indiana University

Professor of Medicine

Single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation.

Single Agent Sunitinib

4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.

Paclitaxel/Sunitinib

4 cycles (8 weeks) of neoadjuvant treatment with AC.

AC Dosing

These patients are for the patients who were into the trial.

Overall Study

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Kathy Miller

From Taghian et al., we used a mean IFP of 6.5 at baseline and a standard deviation of 6.1. We would like to detect a 50% reduction of IFP (to 3.25 mmHg) with sunitinib monotherapy, so the effect size would be 3.25/6.1=0.53. A two-sided paired t-test has 80% power to detect an effect size of .53 and level of significance .05 when the sample size is 30 patients.

Patients who completed the Sunitinib monotherapy segment

Sunitinib Monotherapy

All patients that had both measures at baseline and endpoint in the sunitinib monotherapy segment

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

Patients who finished the paclitaxel plus sunitinib segment

Paclitaxel Plus Sunitinib

All patients in the paclitaxel plus sunitinib segment

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

Patients who finished the AC dosing segment

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

Patients who were in the paclitaxel plus sunitinib segment

All patients who were on paclitaxel plus sunitinib.

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

This is an exploratory phase 2 and biomarker clinical trial of sunitinib in the neoadjuvant setting for the treatment of breast cancer. The study will be conducted in 3 sequential treatment segments. During the first segment, patients will receive single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation. Patients will then begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. Sunitinib will be discontinued after Cycle 5 Day 21. The third segment will include 4 cycles (8 weeks) of neoadjuvant treatment with AC followed by surgical resection and determination of pathological response.

Spots Global Cancer Trial Database for Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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Contact Details

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