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Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) in Patients With Hormone Receptor-Positive Cancers With Recurrence Scores ≥ 25

Phase 2
18 Years
Open (Enrolling)
Breast Neoplasms, Breast Cancer, Cancer of the Breast

Thank you

Trial Information

Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) in Patients With Hormone Receptor-Positive Cancers With Recurrence Scores ≥ 25

Previous studies have shown that chemotherapy has the same effect on treating breast cancer
whether you receive it before or after surgery. Receiving chemotherapy before surgery,
rather than after surgery, may allow you to have less extensive surgery by shrinking the
size of your cancer. The purpose of this study is to assess if docetaxel and cytoxan 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 before surgery,
we will be able to determine if your cancer is responsive to chemotherapy. 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. You will only be eligible to enter this study if the recurrence score
determined using the Oncotype DX assay is 25 or greater. Patients with hormone
receptor-positive breast cancers with recurrence scores greater than or equal to 25 have
been previously demonstrated to obtain a significant benefit from chemotherapy given after

In addition, researchers would like to examine proteins present in your blood and proteins
present in your breast tissue. These additional parts of the study are voluntary and are
NOT required to participate in this study. This consent form will describe these parts of
the study later, in Addendums I and II.

Inclusion Criteria:

- Signed informed consent

- Histologically or cytologically confirmed breast carcinoma.

- Early stage breast cancer (T1c-3, cN0-3, cM0).

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

- 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 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.

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

- 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 Cockroft Gault equation.

- Patients must be at least 18 years of age.

Exclusion Criteria:

- 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:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to pre-operative docetaxel and Cytoxan (TC)

Outcome Description:

Patients will be assessed for surgery after 6 cycles of TC (18 weeks). The primary method of response determination will be by clinical examination, but mammography, breast ultrasound and breast MRI can be used to confirm response or non-response at the discretion of the investigator.

Outcome Time Frame:

approximately 18 weeks

Safety Issue:


Principal Investigator

Amelia Zelnak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

April 2009

Completion Date:

October 2014

Related Keywords:

  • Breast Neoplasms
  • Breast Cancer
  • Cancer of the Breast
  • Breast cancer
  • Tumors, Breast
  • Cancer of the breast
  • Breast Neoplasms
  • Neoplasms
  • Recurrence



Emory University Winship Cancer InstituteAtlanta, Georgia  30322