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
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Palbociclib plus hormonal treatment - first line treatment Patients who initiated Palbociclib + hormonal therapy in the first line treatment |
Drug: Palbociclib plus hormonal treatment - first line treatment
Palbociclib plus hormonal treatment
|
| Palbociclib plus hormonal treatment - second line treatment Patients who initiated palbociclib plus hormonal treatment in the second line treatment |
Drug: Palbociclib plus hormonal treatment - second line treatment
Palbociclib plus hormonal treatment
|
Outcome Measures
Primary Outcome Measures
- Demographic Characteristics of Participants of patients who have received palbociclib combination with aromatase inhibitor [During post-index period (Index date: 60 days after doctor first prescribed palbociclib + partner therapy following the availability of specific indication in the market)]
Main characteristics included were age of patient, menopausal status, stages of the disease, family history of breast cancer
- Clinical Characteristics of Participants of patients who have received palbociclib combination with aromatase inhibitor [During post-index period (Index date: 60 days after doctor first prescribed palbociclib + partner therapy following the availability of specific indication in the market)]
Clinical characteristics of patients include type of breast cancer, stage of the cancer, regions of metastasis, Eastern Cooperative Oncology Group (ECOG) status of the patient
- Number of adjuvant therapies received for the treatment of early or locally advanced breast cancer [During post-index period (Index date: 60 days after doctor first prescribed palbociclib + partner therapy following the availability of specific indication in the market)]
- Number of treatments received in the advanced/metastatic setting, before and after palbociclib combination use [During post-index period (Index date: 60 days after doctor first prescribed palbociclib + partner therapy following the availability of specific indication in the market)]
- Number of Participants With Any Changes in Dosing Associated with Palbociclib use in Clinical Practice [During post-index period (Index date: 60 days after doctor first prescribed palbociclib + partner therapy following the availability of specific indication in the market)]
- Number of Participants With Dosing Interruptions Associated with Palbociclib use in Clinical Practice [During post-index period (Index date: 60 days after doctor first prescribed palbociclib + partner therapy following the availability of specific indication in the market)]
- Number of Participants With Dosing Delays Associated with Palbociclib use in Clinical Practice [During post-index period (Index date: 60 days after doctor first prescribed palbociclib + partner therapy following the availability of specific indication in the market)]
- Number of Participants With Dosing Discontinuations Associated with Palbociclib use in Clinical Practice [During post-index period (Index date: 60 days after doctor first prescribed palbociclib + partner therapy following the availability of specific indication in the market)]
- Number of Supportive Therapies Received by Patients While Receiving Palbociclib Combination Treatments [During post-index period (Index date: 60 days after doctor first prescribed palbociclib + partner therapy following the availability of specific indication in the market)]
- Median Progression Free Survival (PFS) [During post-index period (Index date: 60 days after doctor first prescribed palbociclib + partner therapy following the availability of specific indication in the market)]
- ORR (Objective Response Rate) [During post-index period (Index date: 60 days after doctor first prescribed palbociclib + partner therapy following the availability of specific indication in the market)]
- Mortality rate at the time of reporting [During post-index period (Index date: 60 days after doctor first prescribed palbociclib + partner therapy following the availability of specific indication in the market)]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hemato Oncology Clinic Ahmedabad Private Limited | Rajpath Club Lane ,Gujarat, India | Ahmedabad | India | 380054 |
| 2 | Max Super Speciality Hospital | Patparganj | Delhi, India | India | 110092 |
| 3 | HCG Cancer Centre | Ahmedabad | Gujarat, India | India | 380060 |
| 4 | Indo-American Hospital | Nandi Nagar, Banjara Hills | Hyderabad, Telangana, India | India | 500034 |
| 5 | Bhagwan Mahaveer Cancer Hospital and Research Centre | Bajaj Nagar | Jaipur, Rajasthan, India | India | 302018 |
| 6 | Max Super Speciality Hospital | Saket Institutional Area, | Saket, NEW Delhi, India | India | 110017 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A5481145