EUCTR2010-018389-22-HU
Active, not recruiting
Phase 1
A randomized, multicentre, open-label, Phase II study of the efficacy and safety of lapatinib plus epirubicin and cyclophosphamide (EC90-L) followed by weekly paclitaxel and lapatinib (PX-L) compared with EC90 followed by weekly paclitaxel and trastuzumab (PX-T), as neoadjuvant therapy in patients with previously untreated ErbB2-overexpressing Stage I - IIIA invasive breast cancer with primary tumour size > 1cm. - ELATE
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- patients with previously untreated ErbB2-overexpressing Stage I - IIIA invasive breast cancer with primary tumour size > 1cm.
- Sponsor
- GlaxoSmithKline Research & Development Ltd
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed written informed consent approved by an Independent Ethics Committee
- •(IEC) and obtained prior to any study specific screening procedures.
- •2\. Female patients aged \=18 years.
- •3\. Eastern Cooperative Oncology Group (ECOG) performance status 0 –1\.
- •4\. Histologically confirmed, previously untreated, operable Stage I\-IIIA invasive breast cancer:
- •Primary tumour greater than 1 cm in diameter measured by clinical
- •examination and confirmed by at least one imaging study (mammography,
- •breast ultrasound or MRI).
- •In the case of a multifocal tumour (defined as the presence of two or more
- •foci of cancer within the same breast quadrant), the largest lesion must be \>1
Exclusion Criteria
- •1\. Metastatic, locally advanced, or inflammatory breast cancer as defined by the AJCC
- •(7th Edition).
- •2\. Bilateral breast cancer.
- •3\. Multicentric breast cancer (defined as the presence of two or more foci of cancer in
- •different quadrants of the same breast).
- •4\. Any prior treatment for primary breast cancer (other than excision of tumour in the
- •contralateral breast, and provided that the patient did not previously receive adjuvant radiotherapy or chemotherapy, all of which exclude the patient).
- •5\. Concurrent participation in another clinical trial involving anti\-cancer investigational
- •drug or administration of an investigational drug within 30 days or 5 half\-lives,
- •whichever is longer, preceding the first dose of study treatment.
Outcomes
Primary Outcomes
Not specified
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