Neoadjuvant Chemotherapy Using Doxorubicin and Paclitaxel in Treating Women With Large Breast Cancer
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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: Open Label Primary Purpose: Basic Science |
| Official Title: | Neoadjuvant Chemotherapy in Palpable Breast Cancer: Evaluation of Physiologic, Radiologic, and Molecular Markers in Predicting Response |
- •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 ] [ Designated as safety issue: No ]
| 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 Patients will be randomized into 2 groups based on sequence of neoadjuvant chemotherapy: Doxorubicin followed by Paclitaxel versus Paclitaxel followed by Doxorubicin Other Name: 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 Other Name: Paclitaxel followed by Doxorubicin
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114-2617 | |
| Principal Investigator: | Alphonse G. Taghian, MD, PhD | Dana-Farber Cancer Institute |
More Information
Additional 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, P30CA006516, DFCI-99278 |
| Study First Received: | November 9, 2004 |
| Last Updated: | May 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 Doxorubicin Paclitaxel Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013