Trial · NCT03691493
Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis
NCT03691493, Phase 2, Completed, Emory University; results first posted 2025-02-17
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis. Trials, record NCT03691493. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03691493
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis
- NCT number
- NCT03691493
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Emory University
- Conditions
Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive, HER2/Neu Negative, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Bone, Progesterone Receptor Positive, Prognostic Stage IV Breast Cancer AJCC v8
- Interventions
- Anastrozole, Exemestane, Fulvestrant, Letrozole, Palbociclib, Radiation Therapy, Tamoxifen
- First posted
- 2018-10-01
- Last updated
- 2025-02-17
- Results first posted
- 2025-02-17
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | Up to 3 months post radiation | Response rate will be estimated as the number of responders divided by the number of patients evaluated for response. Among patients who present with pain, responders will be considered those patients who have a 2 point decrease in the Brief Pain Inventory (BPI), and among those who do not present with pain (radiotherapy due to risk of unstable fracture or cord compression), responders will be considered those without development of a pathologic fracture or neurologic compromise (cord compression) due to cancer on imaging. |
| Secondary | Response Rate Incorporating BPI and Analgesic Measures According to International Bone Consensus Guideline Criteria | Up to 3 months post radiation | Response rate will be estimated as the number of responders divided by the number of patients evaluated for response. Among patients who present with pain, responders will be considered those patients who fulfill the International Bone Consensus response criteria using the BPI item rating maximum pain over the last 3 days at the index site and analgesic usage for the treated site within the last 24 hours prior to assessment. Among patients who do not present with pain (radiotherapy due to risk of unstable fracture or cord compression), responders will be considered those without development of a new pathologic fracture or worsening neurologic compromise (cord compression) due to cancer on imaging. |
| Secondary | Number of Participants With Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Up to 3 months post radiation | Adverse events, such as bone fracture following radiotherapy, any grade 3 toxicity (except neutropenia or leukopenia), grade 4 neutropenia, grade 4 leukopenia, grade 3 febrile neutropenia, or grade 3 brachial plexopathy or spinal cord injury, will be summarized descriptively. |
| Secondary | Progression-free Survival (PFS) | Up to 44 months post radiation | PFS will be estimated using the Kaplan-Meier method. |
| Secondary | Overall Survival (OS) | Up to 44 months post radiation | OS will be estimated using the Kaplan-Meier method. |
| Secondary | Fatigue as Measured by The Multidimensional Fatigue Inventory (MFI) | Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiation | Fatigue will be assessed before and after radiotherapy. The Multidimensional Fatigue Inventory (MFI) is a comprehensive self-report instrument designed to measure fatigue. It consists of 20 items rated on a 7-point scale and covers dimensions such as General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation, and Reduced Activity. Each question is score on a 1 to 5 scale, with 1 being 'yes, that is true' and 5 being 'No, that is not true'. The minimum score is 20 and the maximum score is100. The higher the score indicates fatigue. |
| Secondary | Quality of Life as Measured by Short Form Health Survey (SF-36) | Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiation | Quality of life will be assessed before and after radiotherapy. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) Each scale is the weighted sum of the questions in their section and are directly transformed into a 0-100 scale i.e., the minimum score is 0, maximum is 100 A higher score indicates less disability Total score on the SF-36 is the summation of all the eight scales |
| Secondary | Quality of Life as Measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22) | Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiation | Quality of life will be assessed before and after radiotherapy. EORTC QLQ-BM22 measures four multi-item scales: painful sites, functional interference, painful characteristics, and psychosocial aspects Each item is scaled from 1 (not at all) to 4 (very much) and directly transformed into a 0-100 scale A higher score in symptom scales indicates greater distress. A higher score in functional scales indicates greater functional ability |
| Secondary | Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 for Palliative Care (EORTC QLQ-C15-PAL) | Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiation | Quality of life will be assessed before and after radiotherapy. The EORTC QLQ-C15-PAL measures seven scales: physical functioning, global health status, emotional functioning, fatigue, nausea/vomiting, appetite loss, and constipation For questions 1-14, each item is scaled from 1 (not at all) to 4 (very much) . For question 15 (global QoL), patients respond to a seven-point numerical scale from 1 (very poor overall) to 7 (excellent overall). The scale is scored from 0 to 100. A higher score in symptom scales indicates greater distress. A higher score in functional scales indicates greater functional ability. A higher score in global health status indicates a high quality of life. Each subscore is computed using the Addendum to the EORTC QLQ-C30 Scoring Manual: Scoring of the EORTC QLQ-C15-PAL. |
| Secondary | Depression as Measured by Hospital Anxiety and Depression Scale (HADS) | Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiation | Depression will be assessed before and after radiotherapy. The Hospital Anxiety and Depression Scale (HADS) is a 14-item tool used to screen for anxiety and depression, which commonly coexist. The HADS produces a subscale for anxiety (HADS-A) and a separate subscale for depression (HADS-D). The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). The total score is out of 42, (21 per subscale) and the range is 0-42. Scores are derived by summing responses for each of the two subscales or for the scale as a whole. Higher scores indicate greater levels of anxiety or depression. The total HADS score may be regarded as a global measure of psychological distress. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate | Up to 3 months post radiation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Response Rate Incorporating BPI and Analgesic Measures According to International Bone Consensus Guideline Criteria | Up to 3 months post radiation | 27 participants were evaluable | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Up to 3 months post radiation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS) | Up to 44 months post radiation | Months, estimated using the Kaplan-Meier | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Up to 44 months post radiation | Months, estimated using the Kaplan-Meier | MEDIAN | |
| SECONDARY | Fatigue as Measured by The Multidimensional Fatigue Inventory (MFI) | Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiation | Not all patients completed the measure at every timepoint. | Scores on a scale | MEAN |
| SECONDARY | Quality of Life as Measured by Short Form Health Survey (SF-36) | Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiation | Not all patients completed the measure at every timepoint. | Scores on a scale | MEAN |
| SECONDARY | Quality of Life as Measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22) | Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiation | Not all patients completed the measure at every timepoint. | EORT QLQ-BM22 score | MEAN |
| SECONDARY | Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 for Palliative Care (EORTC QLQ-C15-PAL) | Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiation | Not all patients completed the measure at every timepoint. | EORTC QLQ-C15-PAL score | MEAN |
| SECONDARY | Depression as Measured by Hospital Anxiety and Depression Scale (HADS) | Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiation | Not all patients completed the measure at every timepoint. | HADS score, both depression and anxiety | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate | Radiation, Palbociclib, Hormone Therapy | Responders | 29 | Participants | |
| Response Rate | Radiation, Palbociclib, Hormone Therapy | Non-responders | 6 | Participants | |
| Response Rate Incorporating BPI and Analgesic Measures According to International Bone Consensus Guideline Criteria | Radiation, Palbociclib, Hormone Therapy | Responders | 18 | Participants | |
| Response Rate Incorporating BPI and Analgesic Measures According to International Bone Consensus Guideline Criteria | Radiation, Palbociclib, Hormone Therapy | Non-responders | 2 | Participants | |
| Response Rate Incorporating BPI and Analgesic Measures According to International Bone Consensus Guideline Criteria | Radiation, Palbociclib, Hormone Therapy | Intermediate | 7 | Participants | |
| Number of Participants With Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Radiation, Palbociclib, Hormone Therapy | 31 | Participants | ||
| Progression-free Survival (PFS) | Radiation, Palbociclib, Hormone Therapy | 30.4 | 95% Confidence Interval 17.7 to NA | Months, estimated using the Kaplan-Meier | |
| Overall Survival (OS) | Radiation, Palbociclib, Hormone Therapy | 37.9 | 95% Confidence Interval 25.4 to NA | Months, estimated using the Kaplan-Meier | |
| Fatigue as Measured by The Multidimensional Fatigue Inventory (MFI) | Radiation, Palbociclib, Hormone Therapy | Pre-radiation | 55 | Standard Deviation 16.4 | Scores on a scale |
| Fatigue as Measured by The Multidimensional Fatigue Inventory (MFI) | Radiation, Palbociclib, Hormone Therapy | Last Day of radiation | 53.6 | Standard Deviation 13.8 | Scores on a scale |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Radiation, Palbociclib, Hormone Therapy | 36 | |
| Overall Study | COMPLETED | Radiation, Palbociclib, Hormone Therapy | 35 | |
| Overall Study | NOT COMPLETED | Radiation, Palbociclib, Hormone Therapy | 1 |
Source ClinicalTrials.gov
Adverse events155
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Grade 1 Adverse Event | 12 | 36 | |
| other | Anemia | Blood and lymphatic system disorders | Grade 2 Adverse Event | 2 | 36 | |
| other | Anemia | Blood and lymphatic system disorders | Grade 3 Adverse Event | 0 | 36 | |
| other | Anemia | Blood and lymphatic system disorders | Grade 4 Adverse Event | 0 | 36 | |
| other | Anemia | Blood and lymphatic system disorders | Grade 5 Adverse Event | 0 | 36 | |
| other | Anorexia | General disorders | Grade 1 Adverse Event | 2 | 36 | |
| other | Anorexia | General disorders | Grade 2 Adverse Event | 0 | 36 | |
| other | Anorexia | General disorders | Grade 3 Adverse Event | 0 | 36 | |
| other | Anorexia | General disorders | Grade 4 Adverse Event | 0 | 36 | |
| other | Anorexia | General disorders | Grade 5 Adverse Event | 0 | 36 |
1 to 10 of 155Source ClinicalTrials.gov
See all 155 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Grade 1 Adverse Event | 0 | 36 |
| Total, all-cause mortality | Grade 2 Adverse Event | 0 | 36 |
| Total, all-cause mortality | Grade 3 Adverse Event | 0 | 36 |
| Total, all-cause mortality | Grade 4 Adverse Event | 0 | 36 |
| Total, all-cause mortality | Grade 5 Adverse Event | 7 | 36 |
| Total, other adverse events | Grade 1 Adverse Event | 31 | 36 |
| Total, other adverse events | Grade 2 Adverse Event | 30 | 36 |
| Total, other adverse events | Grade 3 Adverse Event | 17 | 36 |
| Total, other adverse events | Grade 4 Adverse Event | 2 | 36 |
| Total, other adverse events | Grade 5 Adverse Event | 0 | 36 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA138292 | Winship Cancer Institute Cancer Center Support Grant | RAMALINGAM, SURESH S | EMORY UNIVERSITY | NATIONAL CANCER INSTITUTE | 2009 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03691493
GET https://conductscience.org/api/trials/v1/NCT03691493/results?page=2