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Randomized, Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) or Exemestane in Patients With Hormone Receptor-Positive Breast Cancers With Recurrence Scores Less Than 25 (≤ 24)

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Randomized, Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) or Exemestane in Patients With Hormone Receptor-Positive Breast Cancers With Recurrence Scores Less Than 25 (≤ 24)

The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or
hormonal therapy using exemestane can shrink the size of your breast tumor and allow you to
preserve your breast or have less extensive surgery on your breast. Additionally, by
receiving chemotherapy or hormonal therapy before surgery, we will be able to determine if
the treatment you receive is effective in treating your cancer. Prior to entering this
study, a special test, called the Oncotype DX assay, will be performed on a small amount of
your cancer from the biopsy you had at the time you were diagnosed with breast cancer, to
determine the likelihood that your cancer will benefit from and shrink with chemotherapy and
hormonal therapy. You will only be eligible to enter this study if the recurrence score of
your cancer determined using the Oncotype DX assay is less than or equal to 24. Patients
with hormone receptor-positive breast cancers with recurrence scores less than or equal to
24 have been previously demonstrated to obtain a larger benefit from hormonal therapy,
compared to chemotherapy, when these agents are given after surgery. The ability of
hormonal agents and chemotherapy to shrink cancers prior to surgery has not been
specifically examined in hormone receptor-positive cancers with recurrence scores less than
or equal to 24.

Inclusion Criteria:

- Signed informed consent

- Histologically or cytologically confirmed breast carcinoma.

- Early stage breast cancer (T1c-3, cN0-3, CM0).

- Pre-treatment biopsy with the following characteristics:

- Hormone receptor-positive cancer as defined as ER and/or PR-positive by standard
immunohistochemistry (IHC)

- HER2-negative (HER2 ≤ 2 by IHC; if HER2 2+ by IHC must be FISH non-amplified)

- Recurrence score < 25 using Oncotype DX 21-gene recurrence score assay

- Patients must have measurable disease as defined by palpable lesion with both
diameters >1cm measurable with caliper or a positive mammogram or ultrasound with at
least one dimension >1cm.

- Baseline measurements of the indicator lesions must be recorded on the Patient
Registration Form. To be valid for baseline, the measurements must have been made
within the 14 days (28 days for x-rays and scans) immediately preceding patient's
entry in study.

- ECOG performance status 0 to 2.

- Adequate organ function within 14 days of study entry:

- Bone Marrow function: Absolute neutrophil count (ANC) ≥ 1500/mm3, Hgb >8.0 g/dl
and platelet count ≥ 100,000/mm.3

- Hepatic function: Total bilirubin < upper limit of normal (ULN). SGOT(AST) or
SGPT(ALT) and Alkaline Phosphatase ≤ 1.5 x ULN).

- Renal function: Calculated CrCl > 30mL/min using the Cockcroft Gault equation.

- Patients must be at least 18 years of age.

Exclusion Criteria:

- No evidence of disease outside the breast or chest wall, except ipsilateral axillary
or internal mammary lymph nodes.

- No prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for
breast cancer.

- Pregnant or lactating women are not eligible. Women of childbearing potential must
have a negative serum pregnancy test completed within 7 days of study entry, and use
an appropriate form of birth control throughout the trial period.

- No medical, psychological or surgical condition which the investigator feels might
compromise study participation.

- No patients with history within the last 5 years of previous or current malignancy at
other sites with the exception of adequately treated carcinoma in-situ of the cervix
or basal or squamous cell carcinoma of the skin. Patients with a history of other
malignancies who remain disease free for greater than five years are eligible.

- No evidence of peripheral or sensory neuropathy.

- Patients with a history of severe hypersensitivity reaction to docetaxel or other
drugs formulated with polysorbate 80 are excluded from participation.

- No serious, uncontrolled, concurrent infection(s).

- No clinically significant cardiac disease (e.g. congestive heart failure, symptomatic
coronary artery disease and cardiac arrhythmias not well controlled with medication)
or myocardial infarction within the last 12 months prior to study entry.

- No major surgery within 28 days of study entry.

- No evidence of CNS metastases.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic complete response.

Outcome Time Frame:

After surgery

Safety Issue:


Principal Investigator

Zelnak Amelia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

July 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast, Male
  • Breast, Female
  • Breast Neoplasms
  • Recurrence



Emory University Winship Cancer Institute Atlanta, Georgia  30322