Clinical trial · Interventional
Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors
PREDIX Luminal A - Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors. 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 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.
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 |
| Hormone Receptor Positive Tumor | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palbociclib | Drug | Palbociclib | ALIAS |
| Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- A: Endocrine treatment
- description
- Pre- or perimenopausal women are treated with tamoxifen, alternatively with an LHRH analogue in combination with an aromatase inhibitor (only women); postmenopausal women receive an aromatase inhibitor. The preoperative treatment is continued for further 12 weeks, provided that re-evaluation after 6 weeks, week 10 of the preoperative treatment, does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option
- interventionNames
- Drug: Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin
- type
- EXPERIMENTAL
- label
- B: Endocrine treatment + palbociclib
- description
- Patients receive the same endocrine treatment as in arm A together with palbociclib 125 mg orally days 1-21, followed by a 7-days rest period. The combined treatment is continued for further 12 weeks, provided that re-evaluation after 6 weeks, week 10 of the preoperative treatment, does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 41 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available