Clinical trial · Interventional
Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
A Multicenter Randomized Phase II Study of First Line Treatment With Sequential Administration of Docetaxel, Carboplatin and Herceptin Versus the Administration of Vinorelbine and Herceptin Combination in HER-2 Positive Patients With Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to poor accrual
Summary
Brief summary (as posted)
This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer.
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 |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Herceptin | Drug | Trastuzumab | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)
- interventionNames
- Drug: Docetaxel
- Drug: Carboplatin
- Drug: Herceptin
- type
- EXPERIMENTAL
- label
- 2
- description
- Vinorelbine + Herceptin (VHer)
- interventionNames
- Drug: Herceptin
- Drug: Vinorelbine
Primary outcomes (1)
- measure
- Time to progression between the two treatment arms
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Performance status (WHO) 0-2 * Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received * HER-2 overexpression 2+ or 3+ using IHC or FISH + * Measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents) * No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered) * More than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered * No prior first line chemotherapy for metastatic disease * Endocrine therapy is allowed as adjuvant or first line treatment for metastatic disease * Paraffin block from the primary tumor available in the research lab * Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3) * Adequate liver (Bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl) * Adequate cardiac function (LVEF \> 50%) * Informed consent Exclusion Criteria: * Pregnant or nursing * Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome * Positive pregnancy test * Motor or sensory neuropathy \> grade 1 according to NCIC Τoxicity Criteria * Patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation * History of allergic reaction attributed to docetaxel * Psychiatric illness or social situation that would preclude study compliance * Other concurrent uncontrolled illness. * Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ
References
Publications (0)
Data not yet available