Clinical trial · Interventional
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer
A Randomized, Open-label Study of the Effect of Paclitaxel, Doxorubicin, and CMF Neoadjuvant Chemotherapy, With and Without Herceptin, on Tumor Response in Women With HER2-positive 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)
This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel observational study patients with HER2-negative disease will receive the same chemotherapy without Herceptin.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CMF | Drug | — | UNRESOLVED |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- HER-2+ Trastuzumab, Doxorubicin/Paclitaxel/CMF
- description
- Participants with HER2 proto-oncogene positive breast cancer (HER2+) were treated with trastuzumab 8 milligrams per kilogram (mg/kg), intravenous (IV), on Day 1 of Cycle 1, followed by 6 mg/kg, IV, on Day 1 of Cycle 2 to up a maximum of Cycle 17. Participants also received doxorubicin 60 mg/ square meter (m\^2), IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m\^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF: cyclophosphamide 600 mg/m\^2, IV; methotrexate 40 mg/m\^2, IV; and 5-fluorouracil 600 mg/m\^2, IV, on Day 1 of Cycles 8 through 10.
- interventionNames
- Drug: Trastuzumab
- Drug: Doxorubicin
- Drug: Paclitaxel
- Drug: CMF
- type
- ACTIVE_COMPARATOR
- label
- HER-2+ Doxorubicin/Paclitaxel/CMF
- description
- Participants with HER2 proto-oncogene positive breast cancer were treated with doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m\^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * female patients, \>=18 years of age, with locally advanced breast cancer. Exclusion Criteria: * previous therapy for any invasive malignancy.
References
Publications (0)
Data not yet available