Clinical trial · Interventional
Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases
PREDIX Luminal B - Neoadjuvant Response-guided Treatment of ER Positive Tumors With High Proliferation or Low Proliferation With Metastatic Nodes. Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-Stage Breast Carcinoma | Early Stage Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Estrogen Receptor Positive Tumor | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aromatase Inhibitor + Palbociclib | Drug | — | UNRESOLVED |
| Goserelin + Aromatase Inhibitor + Palbociclib | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Tamoxifen + Palbociclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- A: Weekly Paclitaxel
- description
- Patients receive weekly paclitaxel 80mg/m2, eventually dose-adjusted in relation to side effects, for a 12-week period. Thereafter, treatment is switched to endocrine treatment in combination with palbociclib. Pre- or perimenopausal women and all men are treated with tamoxifen, alternatively with an LHRH analogue in combination with an aromatase inhibitor (only women); postmenopausal women receive an aromatase inhibitor together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period, repeated twice during the second 12-week period
- interventionNames
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- B: Tamoxifen + Palbociclib
- description
- Pre- or perimenopausal women and all men are treated with tamoxifen together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period, repeated twice during a 12-week period. Thereafter, treatment is switched to weekly paclitaxel 80mg/m2, eventually dose-adjusted in relation to side effects, for further 12 weeks.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMatikas A, Tzoras E, Sarafidis M, Sifakis EG, Bjohle J, Barnekow E, Margolin S, Isaksson-Friman E, Kessler LE, Zouzos A, Johansson H, Hellstrom M, Agartz S, Gryback P, Salgkamis D, Zerdes I, Wang K, Hartman J, Acs B, Sun W, Boyaci C, Villacampa G, Pascual T, Gavila J, Prat A, Perou C, Brandberg Y, Bergh J, Hatschek T, Foukakis T. Neoadjuvant palbociclib and endocrine therapy versus chemotherapy in ER + /HER2- breast cancer: a randomized phase II trial. Nat Commun. 2026 Apr 8;17(1):3403. doi: 10.1038/s41467-026-71452-6. PMID 41951647