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A Pilot Study of Neoadjuvant Paclitaxel and Concurrent Radiation With Correlative Molecular Studies in Stage II/III Breast Cancer

18 Years
Not Enrolling
Breast Cancer

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Trial Information

A Pilot Study of Neoadjuvant Paclitaxel and Concurrent Radiation With Correlative Molecular Studies in Stage II/III Breast Cancer



- Evaluate the efficacy of paclitaxel and concurrent radiotherapy (as measured by
pathologic response rates) in patients with stage II or III breast cancer.


- Evaluate the toxicities of this treatment regimen.

- Correlate paclitaxel-induced tumor response with local recurrence-free survival,
distant disease-free survival, and overall survival.

- Evaluate protein expression profiles by mass spectrometry in biopsy material and blood
specimens collected before and after treatment with paclitaxel.


- Neoadjuvant chemotherapy: Patients receive paclitaxel IV over 3 hours on day 1.
Treatment repeats every 21 days for 3 courses in the absence of disease progression or
unacceptable toxicity.

- Chemoradiotherapy: Beginning 3-4 weeks after completion of neoadjuvant chemotherapy,
patients receive paclitaxel IV over 1 hour twice weekly and undergo radiotherapy once
daily, 5 days a week, for 6½ weeks.

- Surgery: At 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical
resection (e.g., modified radical mastectomy or lumpectomy and axillary node

- Adjuvant chemotherapy: Beginning 4-6 weeks after surgery, patients receive doxorubicin
hydrochloride IV over 20 minutes and cyclophosphamide IV over 1 hour on day 1.
Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or
unacceptable toxicity.

- Hormonal therapy: After completion of adjuvant chemotherapy, patients with estrogen
receptor- and/or progesterone receptor-positive tumor receive hormonal therapy at the
discretion of the treating physician.

Patients undergo blood and tissue sample collection periodically to analyze changes in cell
cycle by flow cytometry; antibody assays; kinase assays for cyclin B1/CDC2; genetic assays
for p53, p21, and other molecular markers; and protein expression assays by mass

After completion of study therapy, patients are followed periodically.

Inclusion Criteria


- Histologically or cytologically documented invasive carcinoma of the breast*

- Tumor ≥ 2 cm in greatest dimension (e.g., T2-4) and any nodal status (e.g.,
N0-3), including locally advanced disease, as defined by the following criteria:

- Primary tumor ≥ 5 cm

- Tumor of any size with direct extension to the chest wall or skin

- Inflammatory breast cancer (T4d)

- Metastasis to ipsilateral internal mammary node

- Ipsilateral lymph nodes that are clinically fixed to each other or to other
structures (N2) NOTE: *Diagnosis may be made by core or tru-cut biopsies

- Measurable or evaluable tumor

- Measurable disease is defined as any mass that can be reproducibly measured in
two perpendicular dimensions

- Evaluable disease is defined as any lesion visible by mammogram or palpable by
physical exam that does not fit the above criteria of measurability

- Planning to undergo breast conservation surgery

- Willing to undergo AND is a candidate for radiotherapy, in the judgement of the
treating radiation oncologist

- No evidence of distant metastatic disease (e.g., lung, liver, bone, brain)

- Hormone receptor status not specified


- Menopausal status not specified

- ECOG performance status 0-1

- WBC ≥ 3,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- Left ventricular ejection fraction ≥ 45%

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancies within the past 5 years, except curatively treated
nonmelanomatous skin cancer or carcinoma in situ of the cervix

- No history of hypersensitivity reaction to products containing polysorbate 80 (Tween

- No serious medical illness that, in the judgment of the treating physician, places
the patient at risk

- No peripheral neuropathy ≥ grade 2


- Prior tamoxifen as chemoprevention allowed

- No prior radiotherapy to the ipsilateral breast

- Prior radiotherapy to the contralateral breast is allowed

- No prior chemotherapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic Complete Response Rate

Outcome Time Frame:

9 weeks

Safety Issue:


Principal Investigator

A. Bapsi Chakravarthy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Federal Government

Study ID:

VCC BRE 9936



Start Date:

February 2000

Completion Date:

November 2004

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms



Williamson Medical CenterFranklin, Tennessee  37067
Meharry Medical CollegeNashville, Tennessee  37208-3599
Boston Baskin Cancer CenterMemphis, Tennessee  38104
Vanderbilt-Ingram Cancer CetnerNashville, Tennessee  
Jackson-Madison HospitalJackson, Tennessee  38301
Methodist Lebonheur HealthcareMemphis, Tennessee  38104