Clinical trial · Interventional
Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
NCT00270894CI-TRIAL-00006547completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients: * trastuzumab (Herceptin) * epirubicin (Ellence) * cyclophosphamide (Cytoxan) * docetaxel (Taxotere)
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| epirubicin | Drug | Epirubicin | ALIAS |
| trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant therapy
- description
- Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.
- interventionNames
- Drug: epirubicin
- Drug: cyclophosphamide
- Drug: docetaxel
- Drug: trastuzumab
Primary outcomes (2)
- measure
- Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule
- timeFrame
- From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)
- description
- Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with \> 85% of the protocol-specified dose.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Non-pregnant females =/\> 18 years of age * Non-inflammatory breast cancer stage IIA - IIIC or high risk node negative * Core biopsy of breast demonstrating invasive cancer and documented ER/PgR receptor status * Normal cardiac function and adequate hematologic function * Human epidermal growth factor receptor 2 protein (HER2) positive * No evidence of metastatic disease * ECOG Performance Status 0 - 1 * Women of childbearing potential must agree to using effective contraception while on treatment and for at least 3 months post-treatment Exclusion Criteria: * Treated with other investigational drugs within 30 days * Uncontrolled intercurrent disease or active infection * Known sensitivity to e. coli-derived proteins or polysorbate 80 * Psychiatric illness or social situation that would limit study compliance * Pre-existing peripheral neuropathy \> Grade 1 * Cancer within 5 years of screening with the exception of surgically cured nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of the breast * Bilateral synchronous breast cancer * Inflammatory breast cancer * Women who are pregnant or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.