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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00096291
First Posted: November 9, 2004
Last Update Posted: April 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alphonse Taghian, MD, PhD, Massachusetts General Hospital
  Purpose

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.


Condition Intervention Phase
Breast Cancer Other: Doxorubicin followed by Paclitaxel Other: Paclitaxel followed by Doxorubicin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neoadjuvant Chemotherapy in Palpable Breast Cancer: Evaluation of Physiologic, Radiologic, and Molecular Markers in Predicting Response

Resource links provided by NLM:


Further study details as provided by Alphonse Taghian, MD, PhD, Massachusetts General Hospital:

Primary Outcome Measures:
  • •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 ]

Enrollment: 62
Study Start Date: February 2000
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sequence Doxorubicin followed by Paclitaxel

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

Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy:

Doxorubicin followed by Paclitaxel Paclitaxel followed by Doxorubicin

Other: 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

Sequence of neoadjuvant CT: 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: 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


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096291


Locations
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114-2617
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
Principal Investigator: Alphonse G. Taghian, MD, PhD Dana-Farber Cancer Institute
  More Information

Publications:
Responsible Party: Alphonse Taghian, MD, PhD, Principle Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00096291     History of Changes
Other Study ID Numbers: CDR0000382123
P50CA089393 ( U.S. NIH Grant/Contract )
P30CA006516 ( U.S. NIH Grant/Contract )
DFCI-99278
First Submitted: November 9, 2004
First Posted: November 9, 2004
Last Update Posted: April 10, 2017
Last Verified: April 2017

Keywords provided by Alphonse Taghian, MD, PhD, Massachusetts General Hospital:
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors