Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01777958
Eligibility Criteria:
Inclusion Criteria:
* Female adult patients, \>/= 18 years of age
* HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable) relapsing after completed adjuvant Herceptin therapy
* Indication for first-line treatment with Perjeta in combination with Herceptin and chemotherapy according to the Summary of Product Characteristics
* Prior Herceptin therapy as systemic adjuvant treatment (postoperative treatment in a potentially curable setting); additional upfront neoadjuvant Herceptin therapy is allowed
* No prior chemotherapy and/or immunotherapy for advanced (metastatic or locally recurrent, inoperable) HER2-positive breast cancer
Exclusion Criteria:
* Pregnant or breastfeeding women
* Contraindications to Perjeta, Herceptin or concomitant chemotherapy according to the Summary of Product Characteristics
* No Herceptin treatment for early breast cancer in the adjuvant setting
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01777958
Study Brief:
Protocol Section:
NCT01777958