A comparison of pre-surgical combination of trastuzumab and pertuzumab with concurrent taxane chemotherapy or endocrine therapy given for twelve weeks with a quality of life assessment of trastuzumab, pertuzumab in combination with standard (neo)adjuvant treatment in patients with operable HER2+/HR+ breast cancer.

Phase 1

• Conditions: Early HER2+/HR+ (triple positiveTP) breast cancer; MedDRA version: 23.0Level: PTClassification code 10065430Term: HER2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-005157-21-DE
• Lead Sponsor: Palleos healthcare GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-21
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 259

Inclusion Criteria

•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:
oNo clinical evidence for distant metastasis (M0)
oClinical cT1c-T4a-c (participation of patients with tumors > cT2 is strongly recommended) and no evidence for distant metastases (M0)
oAll clinical N (participation of patients with cN+, also in case of cT1c, is strongly recommended)
oKnown positive HR-status and centrally confirmed HER2+-status by IHC/FISH
oPatients 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:
oIntrauterine device (IUD)
obilateral tubal occlusion
ovasectomised partner
osexual 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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 207
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

•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:
oUncompensated chronic heart failure or systolic dysfunction (LVEF < 55%, CHF NYHA classes II-IV),
ounstable 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,
oAngina pectoris within the last 6 months requiring anti-anginal medication,
oClinically significant valvular heart disease,
oEvidence of myocardial infarction on electrocardiogram (ECG),
oPoorly controlled hypertension (e.g., systolic > 180 mm Hg or diastolic > 100 mm Hg).
•Inadequate organ function including but not confined to:
ohepatic impairment (Child Pugh Class C)
opulmonary disease (severe dyspnea at rest requiring oxygen therapy)
•Abnormal blood values:
oThrombocytopenia > CTCAE grade 1
oIncreases in ALT/AST > CTCAE grade 1
oHypokalaemia > CTCAE grade 1
oNeutropenia > CTCAE grade 1
oAnaemia > CTCAE grade 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified