Neoadjuvant Chemotherapy Using Doxorubicin and Paclitaxel in Treating Women With Large Breast Cancer

NCT00096291 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000382123P50CA089393P30CA006516DFCI-99278
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• •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

  asses pathological response to neoadjuvant chemotherapy

Study Arms (2)

Sequence Doxorubicin followed by Paclitaxel

ACTIVE COMPARATOR

Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy: Doxorubicin followed by Paclitaxel versus Paclitaxel followed by Doxorubicin

Other: Doxorubicin followed by Paclitaxel; Other: Paclitaxel followed by Doxorubicin

Sequence of neoadjuvant CT: 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

Other: Paclitaxel followed by Doxorubicin

Interventions

Doxorubicin followed by Paclitaxel OTHER

Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy: Doxorubicin followed by Paclitaxel Paclitaxel followed by Doxorubicin

Sequence Doxorubicin followed by Paclitaxel

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

Sequence Doxorubicin followed by Paclitaxel; Sequence of neoadjuvant CT: Paclitaxel followed by Doxorubicin

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114-2617, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Taghian AG, Abi-Raad R, Assaad SI, Casty A, Ancukiewicz M, Yeh E, Molokhia P, Attia K, Sullivan T, Kuter I, Boucher Y, Powell SN. Paclitaxel decreases the interstitial fluid pressure and improves oxygenation in breast cancers in patients treated with neoadjuvant chemotherapy: clinical implications. J Clin Oncol. 2005 Mar 20;23(9):1951-61. doi: 10.1200/JCO.2005.08.119.

  PMID: 15774788 RESULT

• Yeh E, Slanetz P, Kopans DB, Rafferty E, Georgian-Smith D, Moy L, Halpern E, Moore R, Kuter I, Taghian A. Prospective comparison of mammography, sonography, and MRI in patients undergoing neoadjuvant chemotherapy for palpable breast cancer. AJR Am J Roentgenol. 2005 Mar;184(3):868-77. doi: 10.2214/ajr.184.3.01840868.

  PMID: 15728611 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Alphonse G. Taghian, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: February 1, 2000
• Primary Completion: March 1, 2005
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (2)