Overview

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

Status:
Active, not recruiting
Trial end date:
2029-02-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Thomas Hatschek
Treatments:
Aromatase Inhibitors
Exemestane
Goserelin
Hormones
Palbociclib
Tamoxifen
Criteria
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