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Status:

COMPLETED

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

Lead Sponsor:

Massachusetts General Hospital

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

FEMALE

18-120 years

Phase:

PHASE2

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 su...

Detailed 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-a...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 1 2000

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    62 Patients enrolled

    Trial Details

    Trial ID

    NCT00096291

    Start Date

    February 1 2000

    Last Update

    April 10 2017

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, United States, 02114-2617

    2

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

    Boston, Massachusetts, United States, 02115