Metastatic Breast Cancer
Conditions
Keywords
Palbociclib, Africa, Middle East
Brief summary
The objective of this non-interventional multicenter study is to provide prospective, observational data on patients initiating treatment with palbociclib combination to contribute to the knowledge of HR+ HER2-metastatic/locally advanced Breast Cancer (BC) disease management, its treatment pattern, clinical outcomes and quality of life (QoL) in the routine clinical practice in Africa and Middle East countries .
Detailed description
Patients with HR+/HER2- metastatic/locally advanced BC whose treatment decision with palbociclib has been made by their treating physician and who meet the eligibility criteria will be invited to participate in the study. Patients who initiate treatment with palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licensed indication(s), as first or second line therapy for metastatic/locally advanced BC at enrollment may be included in the study. The variables assessed in this study will be patient demographics, clinical characteristics, comorbid conditions and concomitant medications, HR+ HER2-locally advanced and metastatic BC treatment history, current BC treatment, performance status (Eastern Cooperative Oncology Group (ECOG), clinical outcomes, and QoL. All assessments described in this protocol are performed as part of normal clinical practice or standard practice guidelines for the patient population and healthcare provider specialty in the countries where this non-interventional study is being conducted. All data collected in this study are intended to capture the real-world treatment patterns and outcomes for patients with HR+/HER2- metastatic/locally advanced BC. An electronic case report form (eCRF) will be used for data collection. Investigators will be trained with an initial on-site visit to the clinic on the protocol, electronic data capture (EDC) system (i.e., eCRF), investigator site master file (ISMF), documentation, and any applicable study processes. Any new information relevant to the performance of this non-interventional study (NIS) will be forwarded to the medical staff during the study. Remote data monitoring will be conducted during the life of the study to ensure timely reporting of safety data, data integrity and consistency.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years or older with diagnosis of adenocarcinoma of the breast with evidence of metastatic /locally advanced disease not amenable to treatment with curative intent. 2. Documented HR+ (ER+ and/or PR+) tumor based on local standards 3. Documented HER2- tumor based on local standards 4. Will initiate treatment with palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licensed indication(s), as first or second line therapy for metastatic/locally advanced BC at enrollment 5. Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits 6. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
Exclusion criteria
1. Patients participating in any interventional clinical trial 2. Patients on active treatment for malignancies other than metastatic/locally advanced BC at the time of enrollment 3. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Were Progression Free at 6 Months Post Palbociclib Initiation | At 6 months from the date of palbociclib initiation in routine clinical practice | Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the electronic case report form (e-CRF). Kaplan-Meier method was used. |
| Percentage of Participants Who Were Progression Free at 12 Months Post Palbociclib Initiation | At 12 months from the date of palbociclib initiation in routine clinical practice | Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used. |
| Percentage of Participants Who Were Progression Free at 18 Months Post Palbociclib Initiation | At 18 months from the date of palbociclib initiation in routine clinical practice | Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used. |
| Percentage of Participants Who Were Progression Free at 24 Months Post Palbociclib Initiation | At 24 months from the date of palbociclib initiation in routine clinical practice | Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used. |
| Percentage of Participants Who Were Alive at 1 Year Post Palbociclib Initiation | At 1 year from the date of palbociclib initiation in routine clinical practice | Percentage of participants who were alive at 1 year post palbociclib initiation were reported in this outcome measure. |
| Percentage of Participants Who Were Alive at 2 Years Post Palbociclib Initiation | At 2 year from the date of palbociclib initiation in routine clinical practice | Percentage of participants who were alive at 2 years post palbociclib initiation were reported in this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months) | ORR was defined as the percentage of participants with an overall tumor response of complete response (CR) or partial response (PR) or stable disease. Complete response was defined as complete reduction of all visible disease; partial response was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease; stable disease was defined as no change in overall size of visible disease, also including cases where some lesions increased in size and some lesions decreased in size. The responses were evaluated as per local guidelines by the clinician and were collected in the e-CRF. |
| Time From Initial Breast Cancer Diagnosis to Recurrence of Breast Cancer | At baseline (prior to initiation of palbociclib treatment) | Data for time from initial breast cancer diagnosis to recurrence of breast cancer was collected at baseline from participants medical records. |
| Number of Participants According to Stage of Breast Cancer | At baseline (prior to initiation of palbociclib treatment) | Breast cancer stages included Stage I,IIA,IIB,IIIA,IIIB,IIIC as determined using Tumor Node Metastasis (TNM) classification system. Stage I: cancer is small and only in breast tissue or may be found in lymph nodes close to breast. Stage 2: there is cancer in breast or nearby lymph nodes or both. Stage IIA: no tumor found in breast, but cancer is found in one to three axillary lymph nodes, tumor measures 2 centimeter (cm) or smaller; IIB: tumor is larger than 2 cm. Stage 3: cancer is found in lymph nodes close to breast, skin of breast, or chest wall. Stage IIIA: any size tumor; spread to four to nine lymph nodes. Stage IIIB: any size tumor and has spread to chest wall and/or skin of breast and may have spread to up to nine axilliary lymph nodes or near breastbone. Stage IIIC: any size tumor and may have spread to chest wall or skin of breast and ten or more lymph nodes. Higher stage indicates more advanced disease. |
| Number of Participants According to Node Status | At baseline (prior to initiation of palbociclib treatment) | Number of participants classified according to node status were reported in this outcome measure. Node status included: N0, N1, N2, N3, NX. N0: there is no cancer in nearby lymph nodes, N1, N2 and N3: number and location of lymph nodes that contained cancer and NX: cancer is nearby lymph nodes cannot be measured. |
| Number of Participants According to Menopausal Status | At baseline (prior to initiation of palbociclib treatment) | Number of participants classified according to menopausal status were reported in this outcome measure. Menopausal status included: pre-menopausal and post-menopausal. |
| Number of Participants According to Prescribed Palbociclib Combination | At baseline (prior to initiation of palbociclib treatment) | Number of participants classified according to palbociclib combination prescribed (palbociclib plus letrozole/aromatase inhibitor and palbociclib plus fulvestrant) at palbociclib treatment initiation were reported in this outcome measure. |
| Number of Participants According to Sites of Metastases | At baseline (prior to initiation of palbociclib treatment) | Number of participants classified according to sites of metastases (visceral and non-visceral) were reported in this outcome measure. |
| Number of Participants According to Metastatic Status | At baseline (prior to initiation of palbociclib treatment) | Number of participants classified according to metastatic status (denovo advanced BC and recurrent/relapse advanced BC) were reported in this outcome measure. |
| Mean Weight of the Participants | At baseline (prior to initiation of palbociclib treatment) | — |
| Number of Participants Categorized According to Family History of Breast Cancer | At baseline (prior to initiation of palbociclib treatment) | Number of participants categorized according to family history of breast cancer (Yes/No) were reported in this outcome measure. |
| Number of Participants Categorized According to Treatment Schedule | From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months) | Number of participants categorized according to treatment schedule of 3 weeks on, 1 week off (Yes) were reported in this outcome measure. |
| Number of Participants Categorized According to Palbociclib Dose | From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months) | Number of participants categorized according to palbociclib dose (75 milligram \[mg\], 100 mg and 125 mg) were reported in this outcome measure. |
| Number of Participants Categorized According to Accompanying Endocrine Treatments | From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months) | Number of participants categorized according to accompanying endocrine treatments were reported in this outcome measure. Accompanying endocrine treatments included: tamoxifen/NOLVADEX , toremifene / FARESTON, raloxifene / EVISTA, anastrozole / ARIMIDEX, letrozole / FEMARA, exemestane / AROMASIN, fulvestrant / FASLODEX, goserlin acetate / Zoaldex, leuprorelin /Lupron, triptorelin / Decapeptyl, degarelix / Firmagon. One participant may have received more than one endocrine treatment accompanying palbociclib treatment. |
| Number of Participants With Dose Interruption | From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months) | Number of participants with palbociclib dose interruption were reported in this outcome measure. |
| Number of Participants With Dose Delays | From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months) | Number of participants with dose delays were reported in this outcome measure. |
| Number of Participants Who Discontinued Palbociclib Treatment | From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months) | Number of participants who discontinued palbociclib treatment were reported in this outcome measure. |
| Duration of Palbociclib Treatment | From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months) | Duration of palbociclib treatment was defined as time (in days) from first to last day in palbociclib treatment. |
| Number of Participants According to Supportive Therapies Received During Palbociclib Combination Treatment | From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months) | Number of participants according to supportive therapies received during palbociclib combination treatment were reported in this outcome measure. Supportive therapies included: zoledronic acid, calcium supplement, alfacalcidol, letrozole, vitamin D, gabapentin, tramadol, denosumab, granisetron, morphine, filgrastim, metoclopramide, dexamethasone, domperidone, duloxetine, fulvestrant, ondansetron, prednisolone, citalopram, itopride, oxycodone, pregabalin, sertraline. One participant may have received more than one supportive therapy. |
| Number of Participants Categorized According to Adjuvant Therapies | At baseline (prior to initiation of palbociclib treatment) | Number of participants categorized according to adjuvant therapies were reported in this outcome measure. Adjuvant therapies included: adjuvant chemotherapy, adjuvant hormonal therapy, experimental adjuvant therapy, neoadjuvant chemotherapy, neoadjuvant hormonal therapy, radiotherapy and surgery. One participant may have received more than one type of adjuvant therapy. |
| Time Between Start of Palbociclib Treatment and End of Adjuvant Therapy for Early/Locally Advanced Breast Cancer | At baseline (prior to initiation of palbociclib treatment) | Time between start of palbociclib treatment and end of therapy for early/locally advanced BC was calculated as date of initiation of palbociclib treatment - date of end of therapy for early/locally advanced therapy. Time between start of palbociclib treatment and end of adjuvant therapy for early/locally advanced breast cancer was collected at baseline from participant's medical records. |
| Number of Participants According to Therapies Received Before Palbociclib Treatment | At baseline (prior to initiation of palbociclib treatment) | Number of participants according to therapies received before palbociclib treatment were reported in this outcome measure. Therapies included: MBC chemotherapy, MBC hormonal therapy (other than Palbociclib combination), combination therapy, other therapy, radiotherapy and surgery. One participant may have received more than one type of therapy. Therapies for which non-zero data were available have been reported below. |
| Duration of Therapy for Treatment Received Before Palbociclib Treatment | At baseline (prior to initiation of palbociclib treatment) | — |
| Number of Participants According to First Subsequent Therapy Received After Palbociclib Treatment Discontinuation | From palbociclib treatment discontinuation until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months) | Number of participants according to first subsequent therapy received after palbociclib treatment discontinuation were reported in this outcome measure. Subsequent therapies included systemic therapy, radiotherapy, surgery and other therapy. Subsequent therapies for which non-zero data were available have been reported below. |
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Scores | At 6, 12, 18 and 24 months post palbociclib treatment initiation | EORTC QLQ-30 included five functional scales (physical functioning, role, emotional, cognitive and social functioning), nine symptom scales (fatigue, nausea or vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties, and a global health status scale (GHS). The GHS/QoL scale ranged from 1=very poor to 7=excellent. All other items ranged from 1=not at all to 4=very much. A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS and functional scales, and 0 being the best and 100 being the worst for symptom scales. |
Countries
Egypt, Jordan, Lebanon, Qatar, Saudi Arabia
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Participant flow
Pre-assignment details
A total of 185 participants were enrolled in the study. Of these, 183 participants initiated palbociclib treatment and constituted the full analysis set (Full analysis set included all participants who fulfilled the eligibility criteria).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 55-64 years | 52 Participants |
| Age, Customized Greater than equal to (>=) 65 years | 55 Participants |
| Age, Customized Less than (<) 55 years | 76 Participants |
| Race/Ethnicity, Customized Ethnicity Asian / Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian/White | 68 Participants |
| Race/Ethnicity, Customized Ethnicity Middle Eastern | 113 Participants |
| Sex: Female, Male Female | 179 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 183 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
None listed