Clinical trial · Observational
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
Treatment Patterns and Clinical Outcomes Among Indian Patients Receiving Palbociclib Combinations for HR+/HER2- Advanced/Metastatic Breast Cancer in Real World Settings
- 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 clinical study is to describe the patient population, breast cancer treatment, and breast cancer treatment results of adult female patients who have received palbociclib combination treatments for advanced or metastatic breast cancer in India. There are two groups of patients this study will describe. The first group of patients will have received palbociclib in combination with aromatase inhibitor (as prescribed by the Physician) for the treatment of postmenopausal women with HR+/HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The second group of patients will have received palbociclib for the treatment of hormone receptor HR+/HER2- advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.
Conditions
Conditions (5)
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 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Breast Tumors | Breast Neoplasm | ALIAS | 0.90 |
| Cancer of Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palbociclib plus hormonal treatment - first line treatment | Drug | — | UNRESOLVED |
| Palbociclib plus hormonal treatment - second line treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Palbociclib plus hormonal treatment - first line treatment
- description
- Patients who initiated Palbociclib + hormonal therapy in the first line treatment
- interventionNames
- Drug: Palbociclib plus hormonal treatment - first line treatment
- label
- Palbociclib plus hormonal treatment - second line treatment
- description
- Patients who initiated palbociclib plus hormonal treatment in the second line treatment
- interventionNames
- Drug: Palbociclib plus hormonal treatment - second line treatment
Primary outcomes (25)
- measure
- Number of Participants According to the Starting Dose of Palbociclib
- timeFrame
- From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease * Received palbociclib with aromatase inhibitor (as prescribed by the Physician) as initial endocrine therapy in postmenopausal metastatic breast cancer (MBC) patients or with fulvestrant in patients who have progressed on prior endocrine therapy * Patients on Leutinizing Hormone Releasing Hormone (LHRH) agonists for ovarian function suppression in pre- or perimenopausal stage only if prescribed palbociclib with fulvestrant * No prior or current enrolment in an interventional clinical trial for advanced/metastatic breast cancer * Minimum of 3 months of follow up data since palbociclib with fulvestrant initiation, or minimum of 6 months of follow up data since palbociclib with aromatase inhibitor initiation Exclusion Criteria: * Cancers other than breast cancer * Male breast cancer * Visceral crisis
References
Publications (0)
Data not yet available