Trials / Completed
CompletedNCT03809988
PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)
International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 198 (actual)
- Sponsor
- MedSIR · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)
Detailed description
Pre- and post-menopausal women age ≥ 18 years with HR-positive and HER2-negative with ABC that had previously received first-line endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib-based treatment. Patients relapsing on a palbociclib-based regimen in the adjuvant setting are also eligible. Patients are not eligible if they are candidates for a local treatment with a curative intention. Evidence of either measurable and biopsiable metastatic disease (as for Response Evaluation Criteria In Solid Tumors (RECIST v.1.1)) or non-measurable disease with bone lesion is required. Pre-menopausal women must be under treatment with luteinizing hormone-releasing hormone (LHRH) analogues.
Conditions
- Breast Cancer
- Advanced Breast Cancer
- Hormone Receptor Positive Tumor
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Palbociclib | Palbociclib capsules orally once daily (QD) (at 100mg or 125mg depending on previous treatment dose) for 21 days every four weeks |
| DRUG | Endocrine therapy | Endocrine therapy alone (letrozole or fulvestrant) |
Timeline
- Start date
- 2019-04-05
- Primary completion
- 2022-11-30
- Completion
- 2022-11-30
- First posted
- 2019-01-18
- Last updated
- 2023-09-07
Locations
53 sites across 6 countries: France, Germany, Italy, Slovenia, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT03809988. Inclusion in this directory is not an endorsement.