Clinical trial · Interventional
Dose Dense Carboplatin, Taxotere and Herceptin As Primary Systemic Therapy in Breast Cancer
Phase II Study of Dose Dense Carboplatin and Taxotere With Herceptin As Primary Systemic Therapy in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trastuzumab, docetaxel and carboplatin in dose dense regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- arm 1
- description
- single arm study evaluating the efficacy of neoadjuvant taxotere, herceptin and carboplatin given in a dose dense fashion
- interventionNames
- Drug: trastuzumab, docetaxel and carboplatin in dose dense regimen
Primary outcomes (1)
- measure
- Number of Patients With Pathologic Complete Response (pCR)
- timeFrame
- determined at the time of surgery which is approximately 16 weeks from the beginning of treatment
- description
- pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered.
Secondary outcomes (1)
- measure
- Safety and Tolerability
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * HER-2 overexpressing breast cancer * Clinical stage 2-3B * Normal ejection fraction Exclusion Criteria: * Metastatic disease * Low ejection fraction
References
Publications (0)
Data not yet available