Status:
COMPLETED
Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients
Lead Sponsor:
Palleos Healthcare GmbH
Collaborating Sponsors:
Roche Pharma AG
WSG WOMEN´S HEALTHCARE STUDY GROUP
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a prospective, phase IIa, multicenter, randomized, open-label study comparing a pre-surgical combination of trastuzumab and pertuzumab with concurrent weekly paclitaxel chemotherapy or endocri...
Eligibility Criteria
Inclusion
- Female patients, age at diagnosis 18 years and older
- Histologically confirmed unilateral primary invasive carcinoma of the breast
- Patients must qualify for neoadjuvant treatment as follows:
- No clinical evidence for distant metastasis (M0)
- Clinical cT1c-T4a-c (participation of patients with tumors \> cT2 is strongly recommended) and no evidence for distant metastases (M0)
- All clinical N (participation of patients with cN+, also in case of cT1c, is strongly recommended)
- Known positive HR-status and centrally confirmed HER2+-status by IHC/FISH
- Patients need to fulfill adequate blood count and organ function to receive chemotherapy (see exclusion criteria).
- Tumor block available for central pathology review
- Performance Status ECOG ≤ 1 or KI ≥ 80%
- Negative pregnancy test (urine or serum) within 7 days prior to registration in premenopausal patients
- Patients of childbearing potential must accept to implement a highly effective (less than 1% failure rate according to Pearl index) non-hormonal contraceptive measures during the study treatment and for 6 months following the last dose of study treatment (trastuzumab and pertuzumab) such as:
- Intrauterine device (IUD)
- bilateral tubal occlusion
- vasectomised partner
- sexual abstinence
- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
- The patient must be accessible for treatment and follow-up
- LVEF \> 55%; LVEF within normal limits of each institution measured by echocardiography (within 42 days prior to randomization)
- Normal ECG (within 42 days prior to randomization)
Exclusion
- Known hypersensitivity reaction to the compounds or incorporated substances
- Prior malignancy with a disease-free survival of \< 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri
- Non-operable breast cancer including inflammatory breast cancer
- Previous or concurrent treatment with cytotoxic agents for any reason
- Concurrent treatment with other experimental drugs and participation in another clinical trial or clinical research project within 30 days prior to study entry is excluded
- Male breast cancer
- Concurrent pregnancy
- Breastfeeding
- Sequential breast cancer
- Reasons indicating risk of poor compliance
- Known polyneuropathy ≥ grade 2
- Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including but not confined to:
- Uncompensated chronic heart failure or systolic dysfunction (LVEF \< 55%, CHF NYHA classes II-IV),
- unstable arrhythmias requiring treatment i.e., atrial tachycardia with a heart rate ≥ 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade AV-block,
- Angina pectoris within the last 6 months requiring anti-anginal medication,
- Clinically significant valvular heart disease,
- Evidence of myocardial infarction on electrocardiogram (ECG),
- Poorly controlled hypertension (e.g., systolic \> 180 mm Hg or diastolic \> 100 mm Hg).
- Inadequate organ function including but not confined to:
- hepatic impairment (Child Pugh Class C)
- pulmonary disease (severe dyspnea at rest requiring oxygen therapy)
- Abnormal blood values:
- Thrombocytopenia \> CTCAE grade 1
- Increases in ALT/AST \> CTCAE grade 1
- Hypokalaemia \> CTCAE grade 1
- Neutropenia \> CTCAE grade 1
- Anaemia \> CTCAE grade 1
Key Trial Info
Start Date :
October 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2024
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT03272477
Start Date
October 5 2017
End Date
March 4 2024
Last Update
April 17 2024
Active Locations (1)
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1
Evangelisches Krankenhaus Bethesda Mönchengladbach
Mönchengladbach, Germany, 41061