Phase 2
N=257
Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00149214 ↗Enrolled (actual)
257
Serious AEs
15.6%
Results posted
May 2009
Primary outcome: Primary: Number of Participants With a Pathological Complete Response — 21; 24; 99; 89 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pemetrexed (Drug); cyclophosphamide (Drug); doxorubicin (Drug); docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Pathological Complete Response |
21; 24; 99; 89; 7; 6 | — |
| SECONDARY Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy |
8; 9; 45; 43; 49; 44 | — |
| SECONDARY Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy |
19; 21; 59; 60; 35; 24 | — |
| SECONDARY Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery |
64; 63 | — |
| SECONDARY Disease-free Survival |
NA; NA | — |
Summary
An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0).
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 centimeters (cm), of Stages T2-T4/N0-2.
- Performance status 0-2 Eastern Cooperative Oncology Group (ECOG).
- Adequate organ function (bone marrow, hepatic, renal, cardiac).
Exclusion Criteria
- Prior anthracyclines as part of prior anticancer therapy.
- Concurrent antitumor therapy.
- Second primary malignancy.
- Serious concomitant systemic disorder.
- Pre-existing sensorial or motor neuropathy
- Grade 1.
Data sourced from ClinicalTrials.gov (NCT00149214). 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.