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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Palleos Healthcare GmbH
With
Roche Pharma AG
WSG WOMEN´S HEALTHCARE STUDY GROUP
Cankado GmbH
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
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:
* 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
Clareo Health | 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
