Clinical trial · Interventional
A Study of Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer
A Single Arm, Open-label Study to Evaluate the Efficacy on Tumor Response and the Safety of Bevacizumab and Trastuzumab Combination and Sequential Capecitabine in Patients With HER2 +Ive Locally Recurrent or Metastatic Breast Cancer After Early Relapse to Adjuvant Trastuzumab-containing Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patients have been recruited therefore study has been cancelled
Summary
Brief summary (as posted)
This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early relapse on adjuvant Herceptin therapy. Patients will receive Herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every three weeks, and Avastin 15mg/kg every 3 weeks. At first sign of disease progression Xeloda 1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3 weeks) if Xeloda is not indicated for a patient. Anticipated time on study treatment is until disease-progression on second line treatment and target sample size is \<100.
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 |
|---|---|---|---|
| bevacizumab [Avastin] | Drug | Bevacizumab | ALIAS |
| capecitabine [Xeloda] | Drug | Capecitabine | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| trastuzumab [Herceptin] | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: bevacizumab [Avastin]
- Drug: capecitabine [Xeloda]
- Drug: docetaxel
- Drug: trastuzumab [Herceptin]
Primary outcomes (1)
- measure
- Progression-Free Survival on second-line treatment
- timeFrame
- event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter
Secondary outcomes (2)
- measure
- Safety and tolerability: AEs, laboratory parameters, LVEF
- timeFrame
- throughout study, laboratory parameters every 3 weeks, LVEF every 12 weeks
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * male or female patients, age \>/=18 years * locally recurrent or metastatic HER2-positive breast cancer * disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab * LVEF \>/=55% at baseline Exclusion Criteria: * prior treatment with bevacizumab or capecitabine * anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin * chronic daily treatment with corticosteroids (\>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (\>325mg/day), or clopidogrel (\>75mg/day) * clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy * evidence of spinal cord compression or CNS metastasis * history of other malignancy, unless disease-free for \>/=5 years or treated curatively for carcinoma in situ of the cervix or non-melanomatous skin cancer
References
Publications (0)
Data not yet available