Trial · NCT05361655
Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor
NCT05361655, Completed, Pfizer; results first posted 2024-06-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor. Trials, record NCT05361655. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05361655
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor
- NCT number
- NCT05361655
- Status
- Completed
- Enrollment
- 2,888 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Metastatic Breast Cancer
- Interventions
- Palbociclib + an aromatase inhibitor, Aromatase inhibitor
- First posted
- 2022-05-05
- Last updated
- 2024-06-07
- Results first posted
- 2024-06-07
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in Postmenopausal Female or Male Participants With Metastatic Breast Cancer | From index date to death due to any cause or censoring date of 30-Sep-2020 (approximately up to 68 months) | OS was defined as the time from the index date (start of palbociclib + AI or AI alone) to death. Participants who did not die, were censored at the end of study date (30-Sep-2020). Kaplan-Meier method adjusted by stabilized inverse probability of treatment weighting (sIPTW) was used. |
| Secondary | Real-World Progression Free Survival (rwPFS) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | From index date until disease progression or death due to any cause or censoring date (approximately up to 68 months) | Real-world PFS was defined as the number of months from start of palbociclib + AI or AI alone to death from any cause or disease progression (based on clinical assessment or by radiographic scan/tissue biopsy), whichever occurred first. Disease progression was defined as at least a 20 percentage (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that was the smallest on study). Participants who did not die and did not have disease progression were censored at the date of initiation of next line of therapy for participants with 2 or more lines of therapy or at the date of their last visit during the study period (February 2015-September 2020) for participants with only 1 line of therapy. Kaplan-Meier method adjusted by stabilized IPTW was used. |
| Secondary | Number of Participants According to Real-World Tumor Responses (rwTR): Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | From 30 days after index treatment initiation until CR, PR, SD or PD (approximately 67 months) | Real-world best responses were assessed based on treating clinician's assessment of radiological evidence for change in burden of disease over course of treatment after 1 month of index treatment initiation. Responses were classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), indeterminate response (IR). CR=Complete resolution of all visible disease. PR=partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD=no change in overall size of visible disease. PD: an increase in visible disease; also included cases where some lesions increased in size and some lesions decreased in size; included cases where clinician indicated progressive disease; IR=study data not available for evaluation of efficacy for any reason, including participants lost to follow-up or assessment not undertaken or death. Analysis was performed using sIPTW method to balance participant characteristics. |
| Secondary | Real-World Response Rate (rwTR) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | From 30 days after index treatment initiation until disease progression or death due to any cause or censoring date (approximately up to 67 months) | Real-world tumor response rate (rwTR) was defined as the percentage of participants with a real world complete response (rwCR) or real-world partial response (rwPR). CR: complete resolution of all visible disease. PR: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. Analysis was performed using sIPTW method to balance participant characteristics. |
| Secondary | Number of Participants According to Initial Dose of Palbociclib: Palbociclib + Aromatase Inhibitor Arm Only | At index (anytime between 03-Feb-2015 to 31-Mar-2020, approximately up to 62 months) | Number of participants according to the initial dose of palbociclib (75 milligrams \[mg\]/day, 100mg/day, 125 mg/day or missing dose) are reported in this outcome measure. |
| Secondary | Time to Dose Adjustment for Palbociclib- Palbociclib + Aromatase Inhibitor Arm Only | At index (anytime between 03-Feb-2015 to 30-Sep-2020, approximately up to 68 months) | Time to dose adjustment for participants who received palbociclib 125 mg/day, 100 mg/day, or 75 mg/day as initial dose was presented in this outcome measure. |
| Secondary | Duration of Treatment | From start of study treatment to end of treatment, start of subsequent line of therapy, or death from any cause, whichever occurred first (up to 68 months) | Duration of treatment was defined as days from index prescription order date to end of treatment, start of subsequent line of therapy, or death from any cause, whichever occurred first. Kaplan-Meier method adjusted by stabilized IPTW was used. |
| Secondary | Time to Next Line of Treatment | From start of study treatment to start of next line of therapy (up to 68 months) | Time to next line of treatment represents the interval from commencement of one treatment to initiation of the next line of therapy. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. |
| Secondary | Time to Subsequent Chemotherapy | From start of study treatment to administration of different chemotherapeutic agent (up to 68 months) | Time to subsequent chemotherapy represents the time interval to administration of a different chemotherapeutic agent after the first course of therapy was administered. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. |
| Secondary | Real-World Progression Free Survival 2 (rwPFS2) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | From start of study treatment until disease progression, or death from any cause following second line of therapy, whichever occurred first (approximately up to 68 months) | rwPFS2 was defined as the time from the index date to the date of the first documentation of a rwPD or death due to any cause after starting second line of therapy, whichever occurs first. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in Postmenopausal Female or Male Participants With Metastatic Breast Cancer | From index date to death due to any cause or censoring date of 30-Sep-2020 (approximately up to 68 months) | FAS population comprised of all eligible participants enrolled in the study. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. sIPTW method created balanced virtual groups and hence overall number of participants analyzed was different from numbers in participant flow (not balanced). | Months | MEDIAN |
| SECONDARY | Real-World Progression Free Survival (rwPFS) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | From index date until disease progression or death due to any cause or censoring date (approximately up to 68 months) | FAS population comprised of all eligible participants enrolled in the study. Analysis was performed using sIPTW method to balance participant characteristics among reporting groups. sIPTW method created balanced virtual groups and hence overall number of participants analyzed was different from numbers in participant flow(not balanced). | Months | MEDIAN |
| SECONDARY | Number of Participants According to Real-World Tumor Responses (rwTR): Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | From 30 days after index treatment initiation until CR, PR, SD or PD (approximately 67 months) | FAS population comprised of all eligible participants enrolled in the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Real-World Response Rate (rwTR) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | From 30 days after index treatment initiation until disease progression or death due to any cause or censoring date (approximately up to 67 months) | FAS population comprised of all eligible participants enrolled in the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants According to Initial Dose of Palbociclib: Palbociclib + Aromatase Inhibitor Arm Only | At index (anytime between 03-Feb-2015 to 31-Mar-2020, approximately up to 62 months) | FAS population comprised of all eligible participants enrolled in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Dose Adjustment for Palbociclib- Palbociclib + Aromatase Inhibitor Arm Only | At index (anytime between 03-Feb-2015 to 30-Sep-2020, approximately up to 68 months) | FAS population comprised of all eligible participants enrolled in the study. Here 'Overall Number of Participants Analyzed' signifies the total number of participants evaluable for this outcome measure. | Days | MEDIAN |
| SECONDARY | Duration of Treatment | From start of study treatment to end of treatment, start of subsequent line of therapy, or death from any cause, whichever occurred first (up to 68 months) | FAS population comprised of all eligible participants enrolled in the study. sIPTW method created balanced virtual groups and hence overall number of participants analyzed was different from numbers in participant flow (not balanced). | Months | MEDIAN |
| SECONDARY | Time to Next Line of Treatment | From start of study treatment to start of next line of therapy (up to 68 months) | FAS population comprised of all eligible participants enrolled in the study. sIPTW method created balanced virtual groups and hence overall number of participants analyzed was different from numbers in participant flow (not balanced). | Months | MEDIAN |
| SECONDARY | Time to Subsequent Chemotherapy | From start of study treatment to administration of different chemotherapeutic agent (up to 68 months) | FAS population comprised of all eligible participants enrolled in the study. sIPTW method created balanced virtual groups and hence overall number of participants analyzed was different from numbers in participant flow (not balanced). | Months | MEDIAN |
| SECONDARY | Real-World Progression Free Survival 2 (rwPFS2) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | From start of study treatment until disease progression, or death from any cause following second line of therapy, whichever occurred first (approximately up to 68 months) | FAS population comprised of all eligible participants enrolled in the study. sIPTW method created balanced virtual groups and hence overall number of participants analyzed was different from numbers in participant flow (not balanced). | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) in Postmenopausal Female or Male Participants With Metastatic Breast Cancer | Palbociclib + Aromatase Inhibitor | 49.1 | 95% Confidence Interval 45.2 to 57.7 | Months | |
| Overall Survival (OS) in Postmenopausal Female or Male Participants With Metastatic Breast Cancer | Aromatase Inhibitor | 43.2 | 95% Confidence Interval 37.6 to 48.0 | Months | |
| Real-World Progression Free Survival (rwPFS) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | Palbociclib + Aromatase Inhibitor | 19.3 | 95% Confidence Interval 17.5 to 20.7 | Months | |
| Real-World Progression Free Survival (rwPFS) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | Aromatase Inhibitor | 13.9 | 95% Confidence Interval 12.5 to 15.2 | Months | |
| Number of Participants According to Real-World Tumor Responses (rwTR): Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | Palbociclib + Aromatase Inhibitor | Complete response | 163 | Participants | |
| Number of Participants According to Real-World Tumor Responses (rwTR): Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | Aromatase Inhibitor | Complete response | 86 | Participants | |
| Number of Participants According to Real-World Tumor Responses (rwTR): Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | Palbociclib + Aromatase Inhibitor | Partial response | 569 | Participants | |
| Number of Participants According to Real-World Tumor Responses (rwTR): Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | Aromatase Inhibitor | Partial response | 300 | Participants | |
| Number of Participants According to Real-World Tumor Responses (rwTR): Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | Palbociclib + Aromatase Inhibitor | Stable disease | 350 | Participants | |
| Number of Participants According to Real-World Tumor Responses (rwTR): Postmenopausal Female or in Male Participants With Metastatic Breast Cancer | Aromatase Inhibitor | Stable disease | 273 | Participants |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Palbociclib + Aromatase Inhibitor | 1,324 | |
| Overall Study | STARTED | Aromatase Inhibitor | 1,564 | |
| Overall Study | COMPLETED | Palbociclib + Aromatase Inhibitor | 1,324 | |
| Overall Study | COMPLETED | Aromatase Inhibitor | 1,564 | |
| Overall Study | NOT COMPLETED | Palbociclib + Aromatase Inhibitor | 0 | |
| Overall Study | NOT COMPLETED | Aromatase Inhibitor | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Palbociclib + Aromatase Inhibitor | 420 | 1,324 |
| Total, all-cause mortality | Aromatase Inhibitor | 736 | 1,564 |
| Total, other adverse events | Palbociclib + Aromatase Inhibitor | 0 | 0 |
| Total, other adverse events | Aromatase Inhibitor | 0 | 0 |
| Total, serious adverse events | Palbociclib + Aromatase Inhibitor | 0 | 0 |
| Total, serious adverse events | Aromatase Inhibitor | 0 | 0 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Palbociclib + Aromatase Inhibitor vs Aromatase Inhibitor: deaths from any cause |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05361655
GET https://conductscience.org/api/trials/v1/NCT05361655/results?page=2