Clinical trial · Interventional
A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer
An Open-Label, Randomized Phase II Study of Herceptin (Trastuzumab), Taxotere (Docetaxel), and Xeloda (Capecitabine) in Combination, Versus Herceptin (Trastuzumab) Plus Taxotere (Docetaxel), in Patients With Advanced and/or Metastatic Breast Cancers That Overexpress HER2
NCT02748213CI-TRIAL-00024866completedPhase 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)
This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herceptin | Drug | Trastuzumab | ALIAS |
| Taxotere | Drug | Docetaxel | ALIAS |
| Xeloda | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Herceptin + Taxotere
- description
- Participants will receive dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal.
- interventionNames
- Drug: Taxotere
- Drug: Herceptin
- type
- EXPERIMENTAL
- label
- Herceptin + Taxotere + Xeloda
- description
- Participants will receive triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal.
- interventionNames
- Drug: Xeloda
- Drug: Taxotere
- Drug: Herceptin
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, HER2-positive advanced and/or metastatic breast cancer not amenable to curative therapy * At least one measurable lesion according to RECIST * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Baseline left ventricular ejection fraction (LVEF) at least 50% Exclusion Criteria: * Pregnant, lactating, or women of childbearing potential who are not surgically sterile or not willing to use adequate contraceptive methods * Previous treatment with Herceptin or other anti-HER therapies, or any previous chemotherapy for advanced or metastatic disease * Past medical history significant for any cardiac or central nervous system (CNS) disorders * Poor hematologic, renal, or hepatic function * Chronic corticosteroid therapy
References
Publications (1)
- DERIVEDHoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2. PMID 34037241