Clinical trial · Interventional
Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy (PHARE-C)
Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy, a Randomised Comparison of Trastuzumab vs Trastuzumab+Paclitaxel in Women With HER2-positive Early Breast Cancer Receiving Neoadjuvant Treatment
- 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)
RATIONALE: According to previous results from PHARE study, a subgroup of patients with low-risk cancer (\< 3 cm) without axillary lymph node involvement or small (\< 2 cm) with minimal lymph node involvement (1 positive node) presented low risk of recurrence. Maintaining chemotherapy in this subgroup could cause toxicity and it is not yet known whether giving trastuzumab as monotherapy in neoadjuvant setting is as effective as giving trastuzumab combined with paclitaxel in patients with low risk early breast cancer. PURPOSE: This randomized phase III trial is studying trastuzumab as monotherapy in neoadjuvant setting to see if this treatment regimen is as efficient compared to trastuzumab combination with paclitaxel chemotherapy in treating women with low risk (tumor size\< 3 cm, N0) early 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 |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel + Trastuzumab | Drug | — | UNRESOLVED |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A (Paclitaxel + Trastuzumab)
- interventionNames
- Drug: Paclitaxel + Trastuzumab
- type
- EXPERIMENTAL
- label
- Group B (Trastuzumab)
- interventionNames
- Drug: Trastuzumab
Primary outcomes (1)
- measure
- Time to progression
- timeFrame
- up to 5 years
- description
- Time from the date of randomization to the date of progression
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the breast, nonmetastatic disease and non operated tumor * Without suspicious axillary nodes * Tumor size \< 30 mm * Eligibility to receive a weekly paclitaxel based chemotherapy for this cancer * Left Ventricular Ejection Fraction (LVEF) obtained and \> 50% as measured by echocardiography (Simpson method) or multigated acquisition scan (MUGA) at 3 months (-/+ 1 month) * Overexpression of HER-2 in the invasive component of the primary tumor as indicated by one of the following: 3+ by immunohistochemistry (IHC) 2+ by IHC and confirmation by fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) * With signed Informed consent Exclusion Criteria: * Previous anti-HER2 treatment (except for HERCEPTIN) * Cardiac disease or other medical conditions preventing trastuzumab administration * Known allergy to trastuzumab, murine proteins or other excipients * Pregnant or breastfeeding women * Patients that are not able to comply to the protocol assessments for geographic, social or psychological reasons
References
Publications (0)
Data not yet available