Phase 2
Completed N=65
Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer
Source: ClinicalTrials.gov NCT00191789 ↗Enrolled (actual)
65
Serious AEs
26.2%
Results posted
Jul 2010
Primary outcomePrimary: Number of Patients With Pathological Complete Response (Pathological Complete Response Rate) — 13 participants
Summary
Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Pathological Complete Response (Pathological Complete Response Rate) |
13 | — |
| SECONDARY Summary of Deaths During Study |
0; 1; 1; 2; 1 | — |
| SECONDARY Progression Free Survival (PFS) |
— | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Time to Treatment Failure |
— | — |
| SECONDARY Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery |
0; 18 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of breast carcinoma
- No previous chemotherapy, with bidimensionally measurable locally advanced disease
- Adequate performance status (Karnofsky Performance Status [KPS] greater than or equal to 70), bone marrow reserves, hepatic, cardiac and renal functions.
Exclusion Criteria
- Inflammatory breast cancer
- Pregnancy and Breast-feeding
- Serious concomitant disorder or infection
- Previous cancer within the last 5 years or a second primary malignancy.
Data sourced from ClinicalTrials.gov (NCT00191789). 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.