Early HER2+/HR+ (triple positiveTP) breast cancer MedDRA version: 23.0 Level: PT Classification code 10065430 Term: HER2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Perjeta
Product Name: Pertuzumab
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Perjeta
Product Name: Pertuzumab
Pharmaceutical Form: Concentrate for solution for
Sponsors
Palleos healthcare GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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: o No clinical evidence for distant metastasis (M0) o Clinical cT1c-T4a-c (participation of patients with tumors > cT2 is strongly recommended) and no evidence for distant metastases (M0) o All clinical N (participation of patients with cN+, also in case of cT1c, is strongly recommended) o Known positive HR-status and centrally confirmed HER2+-status by IHC/FISH o 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: o Intrauterine device (IUD) o bilateral tubal occlusion o vasectomised partner o 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) 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
Exclusion criteria: • Known hypersensitivity reaction to the compounds or incorporated substances • Prior malignancy with a disease-free survival of 180 mm Hg or diastolic > 100 mm Hg). • Inadequate organ function including but not confined to: o hepatic impairment (Child Pugh Class C) o pulmonary disease (severe dyspnea at rest requiring oxygen therapy) • Abnormal blood values: o Thrombocytopenia > CTCAE grade 1 o Increases in ALT/AST > CTCAE grade 1 o Hypokalaemia > CTCAE grade 1 o Neutropenia > CTCAE grade 1 o Anaemia > CTCAE grade 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective To show superiority of pathological complete response (pCR) prevalence in patients treated with paclitaxel + trastuzumab + pertuzumab versus patients treated with endocrine therapy + trastuzumab + pertuzumab.;Secondary Objective: Secondary objectives i. To assess health-related quality of life (HRQL) during 52 weeks of treatment under dual HER2 blockade. ii. To compare further pCR definitions by treatment arm. iii. To compare clinical response and pCR by treatment arm. iv. To compare prevalence of breast conservation therapy with mastectomy by treatment arm. v. To assess and compare overall survival in both treatment arms. vi. To assess and compare invasive disease-free survival in both treatment arms.;Primary end point(s): Primary efficacy (i.e. pCR) is defined at time of surgery after 12 weeks of neoadjuvant therapy according to NCCN guidelines (no invasive cancer in both breast and lymph nodes, i. e. ypT0/is, ypN0).;Timepoint(s) of evaluation of this end point: after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.) Patient reported outcome as measured by EORTC QLQ-C30, EORTC QLQ-BR23 and EQ-5D using the CANKADO ePRO device 2.) pCR definitions: ypT0/is, any ypN; ypT0/ypN0, near pCR (ypT1a/is, any ypN) 3.) Clinical response measured by i) palpation, ii) ultrasound, and iii) mammography; iv) pCR defined as no invasive tumor in breast and lymph nodes (ypN0/is, ypN0) 4.) Number of breast conservations vs. mastectomies 5.) Overall survival defined as the time between treatment allocation and death due to any cause 6.) Invasive disease-free survival defined as time from treatment allocation to any invasive relapse, second cancer or death;Timepoint(s) of evaluation of this end point: 1.) Neoadjuvant phase (neo) : at baseline visit (day 1 of cycle 1) of wk 1 and at wk 13 (EOT); Adjuvant (ad) phase : every 3 months of T+P treatment (wk 13, 25, 37 and EOT) 2.) at surgery after 12 weeks of neo treatment 3. i) Neo phase: at screening, before cycle 2 (wk 4), cycle 3 (wk7) and EOT week 13; Ad phase: standard of care ii) Neo phase: within 3 months of randomization, before cycle 2 (wk 4), cycle 3 (wk7) and EOT wk 13; Ad phase: standard of care iii) within 3 months prior to randomization and at surgery after 12 wks of neo treatment and EOT wk 13 iv) as in 2) 4.) as in 2) 5.) as in 2) Patients who are alive (including last to follow up) at the time of the analysis will be censored at the last known alive date 6.) as in 2) | — |
Countries
Germany
Contacts
Public ContactClinical Trials Information
Palleos healthcare GmbH
Outcome results
None listed