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

Pfizer

Status: Completed

Conditions: Cancer of Breast; Breast Tumors; Breast Cancer; Breast Neoplasms; Breast Carcinoma

Treatments: Drug: Palbociclib plus hormonal treatment - second line treatment; Drug: Palbociclib plus hormonal treatment - first line treatment

Study type: Observational

Funder types: Industry

Identifiers

NCT05584644

A5481145

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Palbociclib plus hormonal treatment - first line treatment

Description:

Patients who initiated Palbociclib + hormonal therapy in the first line treatment

Treatment:

Drug: Palbociclib plus hormonal treatment - first line treatment

Palbociclib plus hormonal treatment - second line treatment

Description:

Patients who initiated palbociclib plus hormonal treatment in the second line treatment

Treatment:

Drug: Palbociclib plus hormonal treatment - second line treatment