Phase 1
Completed N=603
Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer
Source: ClinicalTrials.gov NCT00050167 ↗Enrolled (actual)
603
Serious AEs
62.2%
Results posted
Aug 2011
Primary outcomePrimary: Percentage of Participants With Reoccurrence — 90.7; 87.5 participants
Summary
Primary Objectives:
* Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer.
* Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel.
* Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Reoccurrence |
90.7; 87.5 | — |
| SECONDARY Proportion of Participants With Pathological Complete Response |
— | — |
| SECONDARY Treatment Effectiveness at Eradicating Tumor in the Breast and Lymph Nodes |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients with histologic confirmation of invasive, but non-inflammatory carcinoma of the breast.
- Stage I (T1N0) are not eligible for the neo-adjuvant portion of the protocol.
- High-risk patients (patients with any of the following: high proliferation rate - Ki67 >35% or poorly differentiated tumors (black's modified grade 3); ER/PR negative; lymphovascular invasion) with stage I disease are eligible for adjuvant therapy.
- Patients with pure mucinous carcinomas, tubular carcinomas or pure medullary carcinomas are eligible if the patient's tumor is larger than 3 cm in size or if the patient has tumor involvement of the lymph nodes (>2mm).
- Patients with bilateral breast cancers are eligible.
- Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible as are patients with pN3a (ten or more axillary lymph nodes). Patients with infraclavicular lymph node involvement are NOT eligible.
- Patients must have clinically measurable disease to be treated in the neoadjuvant setting. This includes patients with a non-palpable primary who have histologically proven lymph node (LN) involvement that is clinically palpable and measurable by ultrasound
- Histologic confirmation of invasive tumor will be done by core needle biopsy for patients with intact primary tumors. If patients have undergone adequate core biopsy prior to evaluation at MDACC, repeat core biopsy is optional.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.
- Patients with a prior history of breast cancer are eligible if the current primary breast cancer is of a higher stage than the original breast cancer and the patient has not received any of the current study medications including past doxorubicin.
- Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of > 1,500/mm3, and platelet count > 100,000/mm3. Patients must have adequate liver function with a bilirubin within normal laboratory values. Transaminases (SGPT) may be up to 2.5x upper limit of normal (ULN) if alkaline phosphatase is grade 1.
Data sourced from ClinicalTrials.gov (NCT00050167). 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.