Clinical trial · Interventional
Chemotherapy for Elderly Patients Diagnosed With Localized HER2 Positive Breast Cancer
Neoadjuvant or Adjuvant Chemotherapy Without Anthracyclines for Elderly Patients Diagnosed 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
Why stopped (as posted): No financial support aproved
Summary
Brief summary (as posted)
There is major concern regarding chemotherapy related toxicity in the group of women older than 65 years old diagnosed with human epidermal growth factor receptor 2 (HER2) positive breast cancer (BC). Nevertheless, these patients are at a particularly high risk of breast cancer recurrence and death. Of note, older patients may experience higher risk for Trastuzumabe related cardiotoxicity, especially when this agent is combined with an anthracycline. Recent studies have shown extremely favourable outcomes in early HER2+ BC patients treated with a combination of paclitaxel and trastuzumab, omitting anthracyclines from treatment. Investigators sought to investigate safety and outcome data on a cohort of elderly patients treated with weekly paclitaxel combined with carboplatin and trastuzumab.
Conditions
Conditions (2)
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 |
| HER-2 Positive Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
| Weekly Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trastuzumab and weekly chemotherapy
- description
- Treatment schedule Weekly paclitaxel and Carboplatin at 80mg/m2 and Area under the curve (AUC) of 2, respectively. Weekly trastuzumab will be combined with chemotherapy (at a loading dose of 4mg/kg and a maintenance dose of 2mg/kg). Chemotherapy will be given at D1, D8 and D15 in a 28-day cycle, for a total of 4 treatment cycles. After completion of four chemotherapy cycles, Trastuzumab will be given at a dose of 6mg/kg every 21 days, for a total 14 cycles.
- interventionNames
- Drug: Trastuzumab
- Drug: Weekly Paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Disease Free Survival (DFS)
- timeFrame
- 3 years
- description
- Disease Free Survival was defined as the time from randomization until first relapse (local, regional, or distant), contralateral breast cancer, or death from any cause.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical or Pathological Stage I- IIIA breast adenocarcinoma. * HER2 overexpression or amplification defined by immunohistochemistry staining of +3 or positive fluorescence in situ hybridization (FISH) test. * Age ≥ 65 years old. * WHO performance status less than 2; adequate hematologic (granulocyte count ≥ 2 X 109/L, platelet count ≥100 X109/L) and hepatic (transaminases ≤ 1.5 X the upper limit of normal (ULN), alkaline phosphatases ≤ 2.5 times ULN, and bilirubin ≤ ULN) tests; and normal cardiac function (baseline left ventricular ejection fraction at least ≥ 55%) Exclusion Criteria: * Radiologic imaging of metastatic disease. * History of cardiac disease contraindicating anthracyclines, uncontrolled essential hypertension or diabetes, stroke or any other comorbidity that could potentially compromise chemotherapy treatment, such as chronic obstructive pulmonary disease. * Any previous treatment with anti HER2 therapy.
References
Publications (0)
Data not yet available