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NCT Number: NCT05584644

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

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.

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Key information

Conditions

Breast Cancer Breast Carcinoma Breast Diseases Breast Neoplasms Breast Tumors Cancer of Breast Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

Hemato Oncology Clinic Ahmedabad Private Limited, Rajpath Club Lane ,Gujarat, India, Ahmedabad, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palbociclib plus hormonal treatment - first line treatment

Drug

Palbociclib plus hormonal treatment

Palbociclib plus hormonal treatment - second line treatment

Drug

Palbociclib plus hormonal treatment

Primary outcomes

  1. Number of Participants According to the Starting Dose of Palbociclib

    Time frame: 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)

    Number of participants according to their starting dose (125 milligrams per day [mg/day], 100 mg/day) of palbociclib were reported in this outcome measure. For participants whose dose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  2. Duration of Treatment

    Time frame: From index date to end of treatment, 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)

    Duration of treatment was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  3. Number of Participants Who Had Any Palbociclib Dose Reduction

    Time frame: 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)

    Number of participants according to dose reductions during palbociclib treatment were reported in this outcome measure. Dose was reduced to 100mg and 75 mg. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  4. Number of Participants Who Had Any Interruption in Palbociclib Treatment

    Time frame: 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)

    Number of participants with any interruptions during palbociclib treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  5. Number of Participants Who Had Any Delays in Palbociclib Treatment

    Time frame: 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)

    Number of participants who had any delay in palbociclib treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  6. Number of Participants According to Reasons for Treatment Discontinuation

    Time frame: 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)

    Number of participants classified according to reasons for treatment discontinuations which included increased transaminases, cardiomyopathy was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  7. Number of Participants According to Reasons for Change in Treatment

    Time frame: 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)

    Number of participants classified according to reasons for change in treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  8. Progression Free Survival

    Time frame: From index date to death or disease progression start of new therapy or last available follow-up whichever occurred first,maximum up to approximately 4.5years;available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)

    Progression free survival was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) while on palbociclib, 2) death, 3) start of a new therapy line after final palbociclib dose, if the reason for discontinuation of palbociclib was disease progression, or 4) last available follow-up, whichever occurred first. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  9. Objective Response Rate (ORR)

    Time frame: From index date to CR/PR, 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)

    The objective response rate was defined as the percentage of participants with complete response (CR) and partial response (PR). As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  10. Number of Participants Who Died

    Time frame: From index date to death, 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)

    Number of participants who died were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  11. Overall Survival (OS)

    Time frame: From index date to death due to any cause, (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)

    OS was defined as the time from index date to the date of death due to any cause. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  12. Number of Participants According to Biomarker Status

    Time frame: 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)

    Number of participants classified according to the biomarker status were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  13. Number of Participants With Family History of Breast Cancer

    Time frame: 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)

    Number of participants with family history of breast cancer were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  14. Duration From Breast Cancer Diagnosis to Palbociclib Treatment

    Time frame: 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)

    Duration from breast cancer diagnosis to palbociclib treatment was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  15. Number of Participants According to Stages of Breast Cancer

    Time frame: 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)

    Number of participants classified according to stages (Stage I, II, IIIa, IV) of breast cancer were included in this outcome measure. Stage I indicated the cancer was small and had not spread anywhere else, Stage II indicated the cancer had grown, but had not spread, Stage IIIa indicated the cancer had grown larger and might have spread to the surrounding tissues and/or the lymph nodes. Stage IV indicated the cancer had spread from where it started to at least 1 other body organ, also known as secondary or metastatic cancer. For participants whose breast cancer stage were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  16. Number of Participants According to Node Status

    Time frame: 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)

    Number of participants classified according to node status were included in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  17. Number of Participants According to Menopausal Status

    Time frame: 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)

    Number of participants classified according to menopausal status which included natural and induced were included in this outcome measure. For participants whose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  18. Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

    Time frame: 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)

    ECOG PS was used to assess physical health of participants. ECOG PS grade:0= fully active, able to carry on all pre-disease performance without restriction,1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, 4= completely disabled, cannot carry on any selfcare totally confined to bed or chair confined to bed or chair more than 50% of waking hours and 5= dead. Participants whose ECOG scores were not available reported as 'data not available'. Only those categories with non-zero values were reported. Index date= 60 days after physician first prescribed palbociclib + hormonal following availability of specific indication in market.

  19. Number of Participants According to Metastatic Sites

    Time frame: 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)

    Number of participants classified according to metastatic sites were reported in this outcome measure. Metastatic sites included bone, lung, liver, lymph nodes, others. For participants whose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. Participant could have more than 1 location of metastases.

  20. Number of Participants According to de Novo and Recurrent Disease

    Time frame: 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)

    Participants classified according to status of disease as de novo versus and recurrent disease were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  21. Number of Participants According to Therapies Received for Early Breast Cancer

    Time frame: 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)

    Participants classified according to therapies received for early breast cancer which included adjuvant chemotherapy, adjuvant endocrine therapy, neoadjuvant treatment, radiotherapy, surgery were reported in this outcome measure. For participants whose details were not available was reported under 'data not available'. Participant could have received more than 1 therapy. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  22. Time Since End of Adjuvant Treatment

    Time frame: 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)

    Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  23. Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis

    Time frame: 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)

    Participants were classified according to supportive therapies received for HR+/HER2- diagnosis and were reported in this outcome measure. Supportive therapies included nutritional treatment, bisphosphonates, anti-anxiety, anti-depressant, anti-emetics, non-steroidal anti-inflammatory drugs. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  24. Duration of Supportive Treatments for ABC/MBC

    Time frame: 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)

    Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

  25. Number of Participants According to Reasons for Regimen Change

    Time frame: 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)

    Participants were classified according to reasons for regimen change and were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Treatment Patterns and Clinical Outcomes Among Indian Patients Receiving Palbociclib Combinations for HR+/HER2- Advanced/Metastatic Breast Cancer in Real World Settings

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2022
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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