Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments doxorubicin followed by paclitaxel, paclitaxel followed by doxorubicin
Phase phase 2
Sponsor Massachusetts General Hospital
Collaborator National Cancer Institute (NCI)
Start date February 2000
End date March 2005
Trial size 62 participants
Trial identifier NCT00096291, CDR0000382123, DFCI-99278, P30CA006516, P50CA089393

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before and after surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining after surgery.

PURPOSE: This randomized phase II trial is comparing two different regimens of doxorubicin and paclitaxel to see how well they work in treating women who are undergoing surgery for breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Active Comparator)
Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy: Doxorubicin followed by Paclitaxel versus Paclitaxel followed by Doxorubicin
doxorubicin followed by paclitaxel
Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy: Doxorubicin followed by Paclitaxel Paclitaxel followed by Doxorubicin
paclitaxel followed by doxorubicin
Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy: Doxorubicin followed by Paclitaxel versus Paclitaxel followed by Doxorubicin
(Other)
Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy: Doxorubicin followed by Paclitaxel versus Paclitaxel followed by Doxorubicin
paclitaxel followed by doxorubicin
Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy: Doxorubicin followed by Paclitaxel versus Paclitaxel followed by Doxorubicin

Primary Outcomes

Measure
•Determine whether tumors in women with palpable invasive breast cancer with wild type p53 are more sensitive to doxorubicin than to paclitaxel when given as sequential single-agent neoadjuvant chemotherapy
time frame: asses pathological response to neoadjuvant chemotherapy

Eligibility Criteria

Female participants from 18 years up to 120 years old.

DISEASE CHARACTERISTICS: - Diagnosis of invasive breast cancer - Tumor ≥ 3 cm and palpable - Multiple masses are allowed provided at least 1 mass is ≥ 3 cm - Clinically positive axillary or supraclavicular lymph nodes allowed - Fine needle aspiration or core needle biopsy positive for invasive breast cancer AND/OR fine needle aspiration of lymph nodes positive - HER2/neu-positive OR negative - No inflammatory breast cancer - No distant metastases - Hormone receptor status: - Estrogen receptor (ER)-positive OR ER-negative PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Premenopausal or postmenopausal Performance status - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Granulocyte count ≥ 1,000/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - Bilirubin ≤ 2 times upper limit of normal (ULN) - SGOT ≤ 2 times ULN Renal - Not specified Cardiovascular - LVEF ≥ 50% - No congestive heart failure - No serious conduction system abnormality - No other significant cardiovascular disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Patients with other prior or concurrent malignancies allowed provided they have received no prior chemotherapy AND they are likely to have been cured from a prior malignancy - No severe medical or psychiatric condition that would preclude study compliance - No known HIV positivity PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - No prior hormonal therapy for breast cancer Radiotherapy - No prior radiotherapy for this malignancy Surgery - Not specified

Additional Information

Official title Neoadjuvant Chemotherapy in Palpable Breast Cancer: Evaluation of Physiologic, Radiologic, and Molecular Markers in Predicting Response
Principal investigator Alphonse G. Taghian, MD, PhD
Description OBJECTIVES: Primary - Determine whether tumors in women with palpable invasive breast cancer with wild type p53 are more sensitive to doxorubicin than to paclitaxel when given as sequential single-agent neoadjuvant chemotherapy. - Determine whether tumors with inactivated p53 are more sensitive to paclitaxel than to doxorubicin when given as sequential single-agent neoadjuvant chemotherapy in these patients. Secondary - Correlate other biological markers (physiological and molecular) with tumor response in patients treated with these regimens. - Determine changes in these biological markers during and after neoadjuvant chemotherapy in these patients. - Compare breast MRI, in terms of assessing tumor response, with physical exam, mammogram, and ultrasound in patients treated with these regimens. - Determine whether there are MRI indicators (e.g., tumor morphology or lesion enhancement) that are predictive of response in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor size (> 5 cm vs ≤ 3-5 cm) and presence of palpable regional lymph nodes (yes vs no). Patients are randomized to 1 of 2 treatment arms. All patients undergo biopsy, bilateral mammogram, MRI, ultrasound, blood marker, molecular (gene microarrays and functional p53 status), and physiologic studies before initiation of neoadjuvant chemotherapy. Some of these studies are repeated after completion of treatment with the first chemotherapeutic agent and after completion of treatment with the second chemotherapeutic agent as outlined below. - Arm I: Patients receive doxorubicin IV on days 1, 15, 29, and 43. Patients with no residual tumor (indicated by clinical evaluation and radiologic studies) after completion of doxorubicin undergo definitive surgery. After surgery, patients receive paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, 36, 43, 50, and 57. Patients with residual tumor > 2 cm after completion of doxorubicin undergo 8-12 core needle biopsies. Patients with residual tumor < 2 cm after completion of doxorubicin undergo 4-6 core needle biopsies. After core needle biopsies, patients receive paclitaxel as above. - Arm II: Patients receive paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, 36, 43, 50, and 57. Patients with no residual tumor (indicated by clinical evaluation and radiologic studies) after completion of paclitaxel undergo definitive surgery. After surgery, patients receive doxorubicin IV on days 1, 15, 29, and 43. Patients with residual tumor > 2 cm after completion of paclitaxel undergo 8-12 core needle biopsies. Patients with residual tumor < 2 cm after completion of paclitaxel undergo 4-6 core needle biopsies. After core needle biopsies, patients receive doxorubicin as above. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Samples from core needle biopsies are analyzed by microarray analysis for gene expression profiles. Patients are followed every 6 months for 5 years. PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study within 4-5 years.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.