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
NCT ID: NCT03272477
Last Updated: 2024-04-17
Study Results
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Basic Information
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COMPLETED
PHASE2
257 participants
INTERVENTIONAL
2017-10-05
2024-03-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Paclitaxel+Trastuzumab+Pertuzumab
Neoadjuvant therapy: Trastuzumab and Pertuzumab in a 3-weekly schedule in combination with standard Taxane chemotherapy.
Adjuvant Therapy: Standard of care
Perjeta Injectable Product
Single dose of 840mg (loading dose) day1 cycle 1, 420mg at day1 of each subsequent cycle, every 3 weeks. (The latter cycle is called cycle of treatment and is to be given 4 times in the neoadjuvant phase and 14 times in the adjuvant therapy phase.)
Herceptin
Single dose of 8mg/kg (loading dose) day1 cycle 1; 6mg/kg at day1 of each subsequent cycle body weight every 3 weeks. (This is called cycle of treatment and is to be given four times in the neoadjuvant phase and 14 times in the adjuvant therapy phase.)
Tamoxifen
20 mg per day for a total of 40 weeks in the adjuvant therapy phase.
Paclitaxel
80mg/sqm, day one of each cycle, every week. This is called a cycle of treatment and is to be given for 12 weeks in neoadjuvant therapy phase.
Epirubicin
12 weeks (4cycles) of max. 90mg/sqm in adjuvant therapy phase
Cyclophosphamide
12 weeks (4cycles) of 600 mg/sqm i.v. on day 1+8 or 12 weeks (4cycles) of 500 mg/sqm i.v. on day 1 in adjuvant therapy phase
Anastrozole
1mg per day for a total of 40 weeks in adjuvant therapy phase
Letrozole
2,5 mg/day for a total of 40 weeks in adjuvant therapy phase
Exemestane
25mg/day for a total of 40 weeks in adjuvant therapy phase
Leuprorelin acetate
One injection of 3,75mg every month or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane, for a total of 40 weeks in the adjuvant therapy phase.
Goserelin
3,6mg every 28 days or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane, for a total of 40 weeks in the adjuvant therapy phase.
Biopsy
Core biopsy at screening (outside of protocol), at week 4 after randomization, (at week 14 in addition if neoadjuvant phase is prolonged)
Surgery
Surgery at week 14 after randomization (or later, if neoadjuvant phase is prolonged)
Endocrine+Trastuzumab+Pertuzumab
Neoadjuvant therapy: Trastuzumab and Pertuzumab in a 3-weekly schedule in combination with endocrine therapy.
Adjuvant Therapy: Standard of care
Perjeta Injectable Product
Single dose of 840mg (loading dose) day1 cycle 1, 420mg at day1 of each subsequent cycle, every 3 weeks. (The latter cycle is called cycle of treatment and is to be given 4 times in the neoadjuvant phase and 14 times in the adjuvant therapy phase.)
Herceptin
Single dose of 8mg/kg (loading dose) day1 cycle 1; 6mg/kg at day1 of each subsequent cycle body weight every 3 weeks. (This is called cycle of treatment and is to be given four times in the neoadjuvant phase and 14 times in the adjuvant therapy phase.)
Epirubicin
12 weeks (4cycles) of max. 90mg/sqm in adjuvant therapy phase
Cyclophosphamide
12 weeks (4cycles) of 600 mg/sqm i.v. on day 1+8 or 12 weeks (4cycles) of 500 mg/sqm i.v. on day 1 in adjuvant therapy phase
Anastrozole
1mg per day for 12 weeks in neoadjuvant therapy phase; 1mg per day for a total of 40 weeks max. in adjuvant therapy phase
Letrozole
2,5 mg per day for 12 weeks in neoadjuvant therapy phase; 2,5 mg perday for a total of 40 weeks max. in adjuvant therapy phase
Exemestane
25mg/day for 12 weeks in neoadjuvant therapy phase; 25mg/day for a total of 40 weeks max. in adjuvant therapy phase
Paclitaxel
80mg/sqm, day one of each cycle, every week. This is called a cycle of treatment an is to be given for 12 weeks in the adjuvant phase
Tamoxifen
20mg per day (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase.
Leuporelin acetate
One injection of 3,75mg every month or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase).
Goserelin
3,5mg every 28 days or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase).
Biopsy
Core biopsy at screening (outside of protocol), at week 4 after randomization, (at week 14 in addition if neoadjuvant phase is prolonged)
Surgery
Surgery at week 14 after randomization (or later, if neoadjuvant phase is prolonged)
Interventions
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Perjeta Injectable Product
Single dose of 840mg (loading dose) day1 cycle 1, 420mg at day1 of each subsequent cycle, every 3 weeks. (The latter cycle is called cycle of treatment and is to be given 4 times in the neoadjuvant phase and 14 times in the adjuvant therapy phase.)
Herceptin
Single dose of 8mg/kg (loading dose) day1 cycle 1; 6mg/kg at day1 of each subsequent cycle body weight every 3 weeks. (This is called cycle of treatment and is to be given four times in the neoadjuvant phase and 14 times in the adjuvant therapy phase.)
Tamoxifen
20 mg per day for a total of 40 weeks in the adjuvant therapy phase.
Paclitaxel
80mg/sqm, day one of each cycle, every week. This is called a cycle of treatment and is to be given for 12 weeks in neoadjuvant therapy phase.
Epirubicin
12 weeks (4cycles) of max. 90mg/sqm in adjuvant therapy phase
Cyclophosphamide
12 weeks (4cycles) of 600 mg/sqm i.v. on day 1+8 or 12 weeks (4cycles) of 500 mg/sqm i.v. on day 1 in adjuvant therapy phase
Anastrozole
1mg per day for a total of 40 weeks in adjuvant therapy phase
Letrozole
2,5 mg/day for a total of 40 weeks in adjuvant therapy phase
Exemestane
25mg/day for a total of 40 weeks in adjuvant therapy phase
Leuprorelin acetate
One injection of 3,75mg every month or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane, for a total of 40 weeks in the adjuvant therapy phase.
Goserelin
3,6mg every 28 days or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane, for a total of 40 weeks in the adjuvant therapy phase.
Anastrozole
1mg per day for 12 weeks in neoadjuvant therapy phase; 1mg per day for a total of 40 weeks max. in adjuvant therapy phase
Letrozole
2,5 mg per day for 12 weeks in neoadjuvant therapy phase; 2,5 mg perday for a total of 40 weeks max. in adjuvant therapy phase
Exemestane
25mg/day for 12 weeks in neoadjuvant therapy phase; 25mg/day for a total of 40 weeks max. in adjuvant therapy phase
Paclitaxel
80mg/sqm, day one of each cycle, every week. This is called a cycle of treatment an is to be given for 12 weeks in the adjuvant phase
Tamoxifen
20mg per day (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase.
Leuporelin acetate
One injection of 3,75mg every month or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase).
Goserelin
3,5mg every 28 days or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase).
Biopsy
Core biopsy at screening (outside of protocol), at week 4 after randomization, (at week 14 in addition if neoadjuvant phase is prolonged)
Surgery
Surgery at week 14 after randomization (or later, if neoadjuvant phase is prolonged)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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:
* 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
18 Years
FEMALE
No
Sponsors
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Roche Pharma AG
INDUSTRY
WSG WOMEN´S HEALTHCARE STUDY GROUP
UNKNOWN
Cankado GmbH
INDUSTRY
Palleos Healthcare GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Iris Reiser, PhD
Role: STUDY_DIRECTOR
Palleos Healthcare GmbH
Locations
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Evangelisches Krankenhaus Bethesda Mönchengladbach
Mönchengladbach, , Germany
Countries
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PH002-TP-II
Identifier Type: -
Identifier Source: org_study_id
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