Phase 2
Completed N=26
Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers
Source: ClinicalTrials.gov NCT00941330 ↗Enrolled (actual)
26
Serious AEs
3.9%
Results posted
Apr 2017
Primary outcomePrimary: Pathologic Complete Response — 5; 1; 4; 2 Participants
Summary
The patients are being asked to take part in this study because they have a hormone receptor-positive breast cancer (contains estrogen and/or progesterone receptors) and their doctor has told them that they have an option to receive chemotherapy or hormonal therapy before surgery. 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 their breast tumor and allow them to preserve the breast or have less extensive surgery on their breast.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response |
5; 1; 4; 2; 5; 5 | — |
| SECONDARY Response Rate by Imaging |
9; 2; 6; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent.
- Histologically or cytologically confirmed breast carcinoma.
- Early stage breast cancer (T1c-3, clinically node-negative-3 [cN0-3], CM0).
- Pre-treatment biopsy with the following characteristics:
- Hormone receptor-positive cancer as defined as ER and/or progesterone receptor (PR)-positive by standard immunohistochemistry (IHC)
- HER2-negative (HER2 ≤ 2 by IHC; if HER2 2+ by IHC must be fluorescent in situ hybridization [FISH] non-amplified)
- Recurrence score 8.0 g/dl and platelet count ≥ 100,000/mm³.
- Hepatic function: total bilirubin < upper limit of normal (ULN). Serum glutamic oxaloacetic transaminase (SGOT) (AST) or serum glutamic pyruvic transaminase (SGPT) (ALT) and alkaline phosphatase ≤ 1.5 x ULN).
- Renal function: calculated creatinine clearance (CrCl) ≥ 30 mL/min using the Cockcroft Gault equation.
- Patients must be at least 18 years of age.
Exclusion Criteria
- Evidence of disease outside the breast or chest wall, except ipsilateral axillary or internal mammary lymph nodes.
- 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.
- Medical, psychological or surgical condition which the investigator feels might compromise study participation.
- 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.
- 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.
- Serious, uncontrolled, concurrent infection(s).
- 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.
- Major surgery within 28 days of study entry.
- Evidence of central nervous system (CNS) metastases.
Data sourced from ClinicalTrials.gov (NCT00941330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.