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Clinical Trials in Sweden / NCT02592083
Active, not recruiting Phase 2

Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors

NCT02592083 · tracked via the Priya Life Science Sweden tracker
Sponsor
Thomas Hatschek
Phase
Phase 2
Started
2015-10
Last updated
2020-07-07

Condition(s) studied

Early-Stage Breast CarcinomaHormone Receptor Positive Tumor

Investigational drug(s) / intervention(s)

Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelinAll Tamoxifen trials (39) →All Goserelin trials (26) →Palbociclib →

Study summary

The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of the cdk 4/6 inhibitor palbociclib when added to standard endocrine treatment. Initially, patients receive endocrine treatment for 4 weeks. In case of decrease of proliferation (Ki67) patients are then randomized between either continuous endocrine therapy (arm A) or the same treatment with addition of palbociclib (arm B). Patients with no change of proliferation are allocated to endocrine treatment + palbociclib without randomization (arm C). During the 12-weekly treatment period, clinical and radiological evaluations are performed repeatedly. Switch between the treatment arms A and B is allowed in case of lack of response or due to toxicity. A translational subprotocol is a mandatory part of the study protocol, except for use of PET-CT evaluations.

Eligibility

Sex
FEMALE
Min age
41 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Written informed consent 2. Female patients with non-lobular breast cancer confirmed by histology 3. Tumor and blood samples available. Luminal A type confirmed by immunohistochemistry with ER and PR positive ≥50% and the proliferation marker Ki 67 \<20% and not HER2 amplified 4. Age older than 40 years 5. Primary breast cancer \>20mm without lymph node metastases 6. Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders 7. LVEF \>50% 8. ECOG performance status 0-1 Exclusion Criteria: 1. Metastases, including node metastases in the ipsilateral and/or 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. Age ≤40 years 4. Lobular carcinoma 5. Patients in child-bearing age without adequate contraception 6. Pregnancy or lactation 7. Severe medical or psychiatric disorders where the study treatment or study procedures carry increased risk of deterioration of health status

Primary outcome measure(s)

  • Clinical and Radiological Response — After 16 weeks of preoperative treatment
    Clinical evaluations by use of calliper, radiological evaluations with mammography and ultrasound after 4, 10 and 16 weeks, PET-CT after 10 weeks of treatment, compared with baseline measurements

Trial sites (1)

FacilityCityRegionStatus
Department of Oncology, Karolinska University Hospital Stockholm Sweden

On this site

📄 Ibrance (palbociclib) drug profile →

More Thomas Hatschek trials in Sweden

Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer Active, not recruiting
Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases Active, not recruiting

Other trials for the same condition

Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer Active, not recruiting
Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases 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 NCT02592083 on ClinicalTrials.gov ↗ ← All trials in Sweden