N/A
Completed N=150
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
Breast Cancer · Breast Neoplasms · Breast Tumors · Cancer of Breast
Source: ClinicalTrials.gov NCT05584644 ↗
Enrolled (actual)
150
Serious AEs
2.7%
Results posted
Dec 2023
Primary outcomePrimary: Number of Participants According to the Starting Dose of Palbociclib — 99; 43; 1; 2 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants According to the Starting Dose of Palbociclib |
99; 43; 1; 2; 5; 0 | — |
| PRIMARY Duration of Treatment |
15.08; 11.63 | — |
| PRIMARY Number of Participants Who Had Any Palbociclib Dose Reduction |
13; 1; 1; 0 | — |
| PRIMARY Number of Participants Who Had Any Interruption in Palbociclib Treatment |
9; 1 | — |
| PRIMARY Number of Participants Who Had Any Delays in Palbociclib Treatment |
7; 1 | — |
| PRIMARY Number of Participants According to Reasons for Treatment Discontinuation |
1; 0; 1; 0 | — |
| PRIMARY Number of Participants According to Reasons for Change in Treatment |
10; 3; 5; 0; 12; 4 | — |
| PRIMARY Progression Free Survival |
31.97; 22.33 | — |
| PRIMARY Objective Response Rate (ORR) |
63.81; 77.78 | — |
| PRIMARY Number of Participants Who Died |
8; 3 | — |
| PRIMARY Overall Survival (OS) |
NA; NA | — |
| PRIMARY Number of Participants According to Biomarker Status |
NA; NA | — |
| PRIMARY Number of Participants With Family History of Breast Cancer |
4; 0 | — |
| PRIMARY Duration From Breast Cancer Diagnosis to Palbociclib Treatment |
8.69; 45.50 | — |
| PRIMARY Number of Participants According to Stages of Breast Cancer |
5; 0; 5; 12; 1; 1 | — |
| PRIMARY Number of Participants According to Node Status |
6; 1; 5; 5 | — |
| PRIMARY Number of Participants According to Menopausal Status |
16; 16; 88; 29; 1; 0 | — |
| PRIMARY Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) |
65; 33; 6; 5; 0; 1 | — |
| PRIMARY Number of Participants According to Metastatic Sites |
62; 28; 28; 16; 14; 7 | — |
| PRIMARY Number of Participants According to de Novo and Recurrent Disease |
NA; NA | — |
| PRIMARY Number of Participants According to Therapies Received for Early Breast Cancer |
4; 8; 14; 5; 6; 11 | — |
| PRIMARY Time Since End of Adjuvant Treatment |
NA; NA | — |
| PRIMARY Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis |
37; 7; 8; 2; 5; 1 | — |
| PRIMARY Duration of Supportive Treatments for ABC/MBC |
NA; NA | — |
| PRIMARY Number of Participants According to Reasons for Regimen Change |
NA; NA | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05584644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.