Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases

• Status: Active, not recruiting
• Trial end date: 2031-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of chemotherapy using weekly paclitaxel (arm A) versus the combination of the cdk 4/6 inhibitor palbociclib and standard endocrine treatment (arm B). After 12 weeks treatment is switched crossover. During the 24-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. Postoperatively, patients receive three 3-weekly courses of chemotherapy with a combination of epirubicin and cyclophosphamide.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Hatschek
• Treatments: Albumin-Bound Paclitaxel; Anastrozole; Aromatase Inhibitors; Exemestane; Goserelin; Letrozole; Paclitaxel; Palbociclib; Phenobarbital; Tamoxifen

Criteria

Inclusion Criteria:

1. Written informed consent

2. Female or male patients with breast cancer confirmed by histology

3. Tumor and blood samples available. Luminal B type confirmed by immunohistochemistry or, preferably, genomic profiling using Next-Generation Sequencingwith ER ≥120% and Ki67 ≥20% and not HER2 amplified, or, if aged 40 or younger and/or verified lymph node metastases, luminal A type, defined as ER and PR positive ≥20% and the proliferation marker Ki 67 <20% and not HER2 amplified. Any luminal B, Luminal A with verified lymph node metastases and/or aged 40 or younger

4. Age 18 years or older. Elderly patients in condition adequate for planned therapy

5. Primary breast cancer >20mm in diameter and/or verified regional 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