Neoadjuvant Chemotherapy in Palpable Breast Cancer: Evaluation of Physiologic, Radiologic, and Molecular Markers in Predicting Response
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- •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
Study Overview
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.
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-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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •18 and over
- •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
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •SGOT ≤ 2 times ULN
- •Not specified
- •Cardiovascular
- •LVEF ≥ 50%
- •No congestive heart failure
- •No serious conduction system abnormality
- •No other significant cardiovascular disease
- •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
- •Not specified
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: Doxorubicin followed by Paclitaxel (Other)
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
Intervention: Paclitaxel followed by Doxorubicin (Other)
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
Intervention: Paclitaxel followed by Doxorubicin (Other)
Outcomes
Primary Outcomes
•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
Secondary Outcomes
No secondary outcomes reported
Investigators
Alphonse Taghian, MD, PhD
Principle Investigator
Massachusetts General Hospital