EUCTR2009-013410-26-FR
Active, not recruiting
Phase 1
An open-label, randomized, multicenter, phase II, comparative, exploratory study on neoadjuvant treatment with trastuzumab plus docetaxel versus trastuzumab plus docetaxel plus bevacizumab according to Positon Emission Tomography (PET) value modification in patients with early stage HER2 positive breast cancer - AVATAXHER
Conditionsearly stage HER2 positive breast cancerMedDRA version: 12.0Level: PTClassification code 10057654Term: Breast cancer female
DrugsAVASTIN
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- early stage HER2 positive breast cancer
- Sponsor
- ROCHE SAS
- Enrollment
- 156
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General inclusion criteria:
- •2\. Age \= 18 years
- •3\. Patient must have signed a written informed consent form prior to any study specific screening procedures
- •4\. Patients able to undergo a pre\-treatment PET and a second course PET
- •5\. Affiliated to the ”Sécurité Sociale” or beneficiary to such a regimen
- •Disease specific inclusion criteria:
- •1\. Patient with invasive, T2 or T3 and histologically confirmed breast cancer, who is
- •scheduled to receive neoadjuvant therapy with the objective of conservative surgery
- •(see Appendix 2\)
- •2\. Nx ou N0 or N1 (see Appendix 2\)
Exclusion Criteria
- •Cancer related Exclusion Criteria:
- •1\. Partially or totally lobular carcinoma
- •2\. Inflammatory breast cancer
- •3\. Bifocal and/or bilateral tumor
- •4\. Metastases
- •5\. Previous treatment with chemotherapy, radiation therapy or hormonal therapy for
- •breast tumor
- •6\. Previous history of cancer (other than curatively treated basal and squamous cell
- •carcinoma of the skin and/or in\-situ carcinoma of the cervix) relapsing within the 5
- •years before study entry or in situ contralateral breast carcinoma.
Outcomes
Primary Outcomes
Not specified
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