PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)
NCT03809988 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198
Last updated 2023-09-07
Summary
Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)
Conditions
- Breast Cancer
- Advanced Breast Cancer
- Hormone Receptor Positive Tumor
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Interventions
- DRUG
-
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)
Sponsors & Collaborators
- collaborator INDUSTRY
-
MedSIR
lead OTHER
Principal Investigators
-
José Perez · MedSIR
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-05
- Primary Completion
- 2022-11-30
- Completion
- 2022-11-30
Countries
- France
- Germany
- Italy
- Slovenia
- Spain
- United Kingdom
Study Locations
More Related Trials
-
Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate
NCT02142868 ·Status: NO_LONGER_AVAILABLE
-
Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer
NCT02491983 ·Status: COMPLETED ·Phase: PHASE2
-
Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer
NCT03820830 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Ph II Study of Pembrolizumab & Eribulin in Patients With HR+/HER2- MBC Previously Treated With Anthracyclines & Taxanes
NCT03222856 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer
NCT05584644 ·Status: COMPLETED
-
A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer
NCT06495164 ·Status: ACTIVE_NOT_RECRUITING
-
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
NCT01740427 ·Status: COMPLETED ·Phase: PHASE3
-
Palbociclib and Binimetinib in Advanced Triple Negative Breast Cancer
NCT04494958 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Outcomes Among Patients in Brazil Receiving Palbociclib Combinations for HR+/HER2- MBC
NCT05505175 ·Status: COMPLETED
-
Pembrolizumab + Paclitaxel in HR+/HER2- Non-luminal (by PAM50) Advanced Breast Cancer After CDK4/6 Inhibitor Progression
NCT04251169 ·Status: TERMINATED ·Phase: PHASE2
-
Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced and/or Metastatic Breast Cancer
NCT04874025 ·Status: COMPLETED
-
Treatment Patterns & Clinical Outcomes of Palbociclib Combinations in HR+HER2-MBC
NCT04937660 ·Status: COMPLETED
-
Palbociclib in Real World Practice
NCT03280303 ·Status: COMPLETED
-
Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate
NCT02600923 ·Status: COMPLETED ·Phase: PHASE3
-
Palbociclib Combine With Anti-HER2 Therapy in Triple Positive ABC
NCT05969184 ·Status: UNKNOWN ·Phase: PHASE2
-
Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
NCT02679755 ·Status: COMPLETED ·Phase: PHASE4
-
Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer
NCT02040857 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate Real-world Effectiveness With Palbociclib Plus Endocrine Therapy as First-line/Second-line Treatment for HR+/HER2- Advanced Breast Cancer in Japan
NCT05399329 ·Status: COMPLETED
-
RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
NCT04460898 ·Status: COMPLETED
-
ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL
NCT04603183 ·Status: COMPLETED ·Phase: PHASE2
-
Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant
NCT02894398 ·Status: COMPLETED ·Phase: PHASE2
-
TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB COMBINATION TREATMENT (WITH AI OR FULVESTRANT) FOR HR+/HER2- A/MBC IN A COMMUNITY ONCOLOGY SETTING.
NCT04498481 ·Status: COMPLETED
-
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
NCT04075604 ·Status: COMPLETED ·Phase: PHASE2
-
Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer
NCT02499146 ·Status: COMPLETED ·Phase: PHASE1
-
Patterns of Prescribing and Monitoring of Palbociclib
NCT03285568 ·Status: COMPLETED