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Clinical Trials in Sweden / NCT02568839
Active, not recruiting Phase 2/3

Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer

NCT02568839 · tracked via the Priya Life Science Sweden tracker
Sponsor
Thomas Hatschek
Phase
Phase 2/3
Started
2014-11
Last updated
2020-08-13

Condition(s) studied

Early-Stage Breast CarcinomaHER-2 Positive Breast Cancer

Investigational drug(s) / intervention(s)

docetaxel + trastuzumab sc + pertuzumabAll Docetaxel trials (274) →All Trastuzumab trials (148) →All Pertuzumab trials (89) →trastuzumab emtansin →

docetaxel + trastuzumab sc + pertuzumab: docetaxel 75-100 mg IV + trastuzumab sc 5 ml (600 mg) SC + pertuzumab 840 mg IV starting dose, subsequently 420 mg IV, repeated every 3 weeks, 6 courses

trastuzumab emtansin: trastuzumab emtansine 3.6 mg/kg IV, repeated every 3 weeks, 6 courses

Study summary

The purpose of this trial is to evaluate efficacy and toxicity of either the combination of docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B). Switch of therapy to the opposite treatment alternative is applicable in case of lack of response after two courses of treatment, or for medical reasons under exceptional circumstances (drug reaction, other medical conditions) at any point. After termination of the primary treatment follow-up for five years.

A translational subprotocol is a mandatory part of the study protocol, with exception for the use of PET-CT evaluations.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Written informed consent 2. Patients with breast cancer confirmed by histology, characterized by immunohistochemistry for ER, PR, HER2 and proliferation marker 3. Tumor and blood samples available. HER2 type confirmed by ISH 4. Age 18 years or older. Elderly patients in condition adequate for planned therapy 5. Primary breast cancer \>20mm in diameter and/or verified lymph node metastases 6. Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders 7. LVEF ≥55% 8. ECOG performance status 0-1 9. Primary breast cancer as defined in p. 5 plus at most 2 morphologically characterized well-defined distant metastases accessible for stereotactic radiotherapy, provided that this treatment is available Exclusion Criteria: 1. Distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum 2. Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix 3. Patients in child-bearing age without adequate contraception 4. Pregnancy or lactation 5. Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders

Primary outcome measure(s)

  • Pathological objective response to primary medical treatment — At surgery
    Efficacy measure after 18 weeks of preoperative treatment, starting from the start of preoperative medical treatment until the date of surgery. Outcome should be received within not more than 4 weeks post surgery

Trial sites (7)

FacilityCityRegionStatus
Dept. of Oncology, Örebro University Hospital Örebro Närke
Dept. of Oncology, Sahlgrenska University Hospital Gothenburg Sweden
Dept. of Oncology, Skåne University Hospital Lund Sweden
Dept. of Oncology, Karolinska University Hospital Stockholm Sweden
Dept. of Oncology, Sundsvall Hospital Sundsvall Sweden
Dept. of Oncology, University Hospital of Umeå Umeå Sweden
Dept. of Oncology, Uppsala University Hospital Uppsala Sweden

More Thomas Hatschek trials in Sweden

Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases Active, not recruiting
Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors Active, not recruiting

Other trials for the same condition

Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases Active, not recruiting
Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02568839 on ClinicalTrials.gov ↗ ← All trials in Sweden