Clinical trial · Interventional
To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine Therapy
Phase 2,Open-label,Multicenter,Randomized Study of PD0332991 (Oral CDK4/6 Inhibitor) Monotherapy and in Combination With the HT to Which the pt Has Progressed in the Previous Line for ER+,Her2- Post-menopausal Advanced Breast Cancer Pts
NCT02549430CI-TRIAL-00028880TREndcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study aims to assess the activity of PD0332991 in monotherapy and in combination with the endocrine therapy (anastrozole, letrozole, exemestane or fulvestrant) on which the patient has progressed in the previous line for advanced breast cancer in order to reverse endocrine resistance.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Exemestane | Drug | Exemestane | ALIAS |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
| Palbociclib | Drug | Palbociclib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Palbociclib monoterapy
- interventionNames
- Drug: Palbociclib
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Palbociclib + HT (Anastrozole, Letrozole, Exemestane, Fulvestrant)
- interventionNames
- Drug: Palbociclib
- Drug: Anastrozole
- Drug: Letrozole
- Drug: Exemestane
- Drug: Fulvestrant
Primary outcomes (1)
- measure
- Incidence of complete response (CR), partial response (PR) or stable disease (SD) ≥24 weeks (clinical benefit)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven diagnosis of adenocarcinoma of the breast with evidence of metastatic disease * ER positive tumor ≥ 10% * HER2 negative breast cancer by FISH or IHC * Progression of advanced breast cancer on first or second line endocrine therapy for advanced breast cancer * Paraffin-embedded tumor available for centralized assessment of biomarkers * Measurable disease according to RECIST 1.1 (bone only disease is allowed only if measurable). * Postmenopausal status * Eastern Cooperative Oncology Group (ECOG) Performance status 0 -2 * Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade \>1 * Adequate organ function Exclusion Criteria: * Unstable brain metastases * Prior treatment with more than one line of CT or more than two lines of HT advanced breast cancer or any CDK inhibitor * Current treatment with therapeutic doses of anticoagulant * Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors / inducers, drugs that are predominantly metabolized by CYP3A with narrow therapeutic indices, drugs with the potential of prolonging QT interval * Diagnosis of any secondary malignancy within the last 3 years * Active inflammatory bowel disease or chronic diarrhea * Known human immunodeficiency virus infection; active hepatitis C, active hepatitis B
References
Publications (2)
- DERIVEDGalardi F, De Luca F, Biagioni C, Migliaccio I, Curigliano G, Minisini AM, Bonechi M, Moretti E, Risi E, McCartney A, Benelli M, Romagnoli D, Cappadona S, Gabellini S, Guarducci C, Conti V, Biganzoli L, Di Leo A, Malorni L. Circulating tumor cells and palbociclib treatment in patients with ER-positive, HER2-negative advanced breast cancer: results from a translational sub-study of the TREnd trial. Breast Cancer Res. 2021 Mar 24;23(1):38. doi: 10.1186/s13058-021-01415-w. PMID 33761970
- DERIVEDMalorni L, Curigliano G, Minisini AM, Cinieri S, Tondini CA, D'Hollander K, Arpino G, Bernardo A, Martignetti A, Criscitiello C, Puglisi F, Pestrin M, Sanna G, Moretti E, Risi E, Biagioni C, McCartney A, Boni L, Buyse M, Migliaccio I, Biganzoli L, Di Leo A. Palbociclib as single agent or in combination with the endocrine therapy received before disease progression for estrogen receptor-positive, HER2-negative metastatic breast cancer: TREnd trial. Ann Oncol. 2018 Aug 1;29(8):1748-1754. doi: 10.1093/annonc/mdy214. PMID 29893790