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Pilot Study of Neoadjuvant Dose Dense Docetaxel With Correlative Molecular Studies in Stage II/III Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Pilot Study of Neoadjuvant Dose Dense Docetaxel With Correlative Molecular Studies in Stage II/III Breast Cancer



- Pathologic complete response rate (pCR) of dose dense docetaxel in the neoadjuvant


- Safety and toxic effects of this regimen in these patients.

- Tumor response rate (as measured by ultrasound) in patients treated with this regimen.

- Determine whether early changes in markers of cell cycle position, proliferation, or
apoptosis correlate with pathologic complete response rate in these patients.

- Determine whether the molecular profile that predicts for chemoresponsiveness also
predicts for response to radiotherapy (as measured by local recurrence) in these

- Determine whether tumors that demonstrate the greatest degree of change in protein
expression patterns from pre- to post-docetaxel treatment will also be those that are
most sensitive to chemotherapy (as measured by pathologic response rate) in these

OUTLINE: This is a nonrandomized, open-label, pilot study.

- Tissue Collection: Patients undergo tumor core biopsy (6-8 cores) and blood collection
prior to initiating neoadjuvant docetaxel.

- Neoadjuvant docetaxel with hematopoietic support: Patients receive docetaxel IV over 1
hour on day 1. Patients also receive pegfilgrastim subcutaneously (SC) on day 1 or 2 of
each course OR filgrastim (G-CSF) or sargramostim (GM-CSF) SC daily beginning between
day 2-4 of each course and continuing until blood counts recover. Treatment repeats
every 14 days for up to 4 courses in the absence of disease progression or unacceptable

- Surgery: Within 4-6 weeks after completion of neoadjuvant docetaxel, patients undergo
definitive surgery.

Patients undergo tumor biopsy and blood collection periodically for pharmacokinetic,
genetic, and molecular biomarker correlative studies. Samples are examined for changes in
p21 protein expression (and/or p21 phosphorylation) and the protein expression profile.

After completion of study treatment, patients are followed at least every 6 months for 3
years and then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria



- Histologically or cytologically confirmed invasive carcinoma of the breast by core

- Tumor ≥ 2 cm in greatest dimension(may be either node positive or node negative

- Patients with non-metastatic breast cancer who are in the judgment of the treating
medical oncologist considered to be of sufficiently high risk to warrant adjuvant

- Patients with internal mammary, supraclavicular and/or axillary node involvement
are eligible. Patients with inflammatory breast cancer are eligible

- Patients with T0 disease but palpable and measurable adenopathy are eligible for
this trial. All sites of disease should be noted and followed

- Hormone receptor status:

- Not specified


- ECOG performance status 0-1

- Menopausal status not specified

- Female ≥ 18 years old

- Absolute neutrophil count ≥ 1,000/mm^3

- Hemoglobin ≥ 8 g/dL

- Platelet count ≥ 100,000/mm^3

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

- Bilirubin normal

- Alkaline phosphatase (AP), AST, and ALT meeting 1 of the following criteria:

- AP normal AND AST or ALT ≤ 5 times ULN

- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

- AP ≤ 5 times ULN AND AST or ALT normal

- Women of child-bearing potential, must have a negative serum pregnancy test and must
use effective contraception for the duration of the study and for at least 6 months
after completion of study treatment

- Patients with prior malignancies are eligible if they have been disease free for ≥ 5
years. Patients with curative treatment of non-melanomatous skin cancer, carcinoma in
situ of the cervix, contralateral DCIS treated with mastectomy are eligible even if
it is diagnosed in < 5 years.


- No prior anthracycline or taxane-based chemotherapy. Patients who received
chemoprevention are eligible if the chemopreventive agent has been discontinued for
at least one year prior to enrollment in the current study.

- At least 1 year since prior tamoxifen for breast cancer prevention


- Prior radiotherapy to the ipsilateral breast

- Patients who have had radiation to the contralateral breast are eligible

- Evidence of distant metastatic disease (i.e., lung, liver, bone, brain)

- Pregnant of breastfeeding

- Patients who have congestive heart failure, angina pectoris, uncontrolled cardiac
arrhythmia, or other significant heart disease, or who have had a myocardial
infarction within the past year

- Patients with > grade 1 peripheral neuropathy

- Patients with a history of hypersensitivity reaction to products containing
polysorbate 80 (Tween 80)

- Patients receiving an investigational anticancer drug within 3 weeks of registration

- Patients with serious medical illness that in the judgment of the treating physician,
places the patient at risk.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number Participants to Achieve Pathologic Complete Response

Outcome Description:

whether or not patient has pathologic complete response (pCR) to dose dense docetaxel in the neoadjuvant setting (pCR = no residual viable tumor on histologic analysis)

Outcome Time Frame:

3 month

Safety Issue:


Principal Investigator

A. Bapsi Chakravarthy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2004

Completion Date:

March 2011

Related Keywords:

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



Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Meharry Medical College Nashville, Tennessee  37208-3599