18 and older, any sex, with Anatomic Stage IV Breast Cancer AJCC v8 or Estrogen Receptor Positive. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Response RatePrimary· 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.
Responders
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
29
Non-responders
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
6
Response Rate Incorporating BPI and Analgesic Measures According to International Bone Consensus Guideline CriteriaSecondary· 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
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
18
Radiation, Palbociclib, Hormone Therapy
2
Radiation, Palbociclib, Hormone Therapy
7
Number of Participants With Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0Secondary· 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.
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
31
Progression-free Survival (PFS)Secondary· Up to 44 months post radiation
PFS will be estimated using the Kaplan-Meier method.
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
30.4
17.7 – NA
Overall Survival (OS)Secondary· Up to 44 months post radiation
OS will be estimated using the Kaplan-Meier method.
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
37.9
25.4 – NA
Fatigue as Measured by The Multidimensional Fatigue Inventory (MFI)Secondary· 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.
Pre-radiation
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
55
± 16.4
Last Day of radiation
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
53.6
± 13.8
1-month post radiation
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
54.0
± 16.6
3-month post radiation
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
52.3
± 15.9
Change (Last Day of Radiation - Pre-radiation)
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
0.1
± 11.5
Change (1-month post radiation - Pre-radiation)
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
-0.4
± 15.2
Change (3-month post radiation - Pre-radiation)
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
-1.4
± 12.7
Quality of Life as Measured by Short Form Health Survey (SF-36)Secondary· 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
Pre-radiation
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
41.8
± 8.8
Last Day of radiation
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
42.0
± 8.2
1-month post radiation
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
44.0
± 8.1
3-month post radiation
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
44.0
± 8.2
Change (Last Day of radiation - Pre-radiation)
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
0.2
± 4.7
Change (1-month post radiation - Pre-radiation)
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
2.1
± 6.6
Change (3-month post radiation - Pre-radiation)
Group
Value
95% CI
Radiation, Palbociclib, Hormone Therapy
1.9
± 7.3
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)Secondary· 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
Pre-radiation
Group
Value
95% CI
Treated, Painful Site
28.0
± 21.0
Treated, Pain Characteristics
31.2
± 26.5
Treated, Functional Interference
63.6
± 30.9
Treated, Psychological Aspects
61.0
± 20.9
Last Day of radiation
Group
Value
95% CI
Treated, Painful Site
21.5
± 20.0
Treated, Pain Characteristics
25.0
± 23.7
Treated, Functional Interference
73.4
± 25.8
Treated, Psychological Aspects
68.4
± 19.8
1-month post radiation
Group
Value
95% CI
Treated, Painful Site
18.5
± 15.1
Treated, Pain Characteristics
22.2
± 24.6
Treated, Functional Interference
74.1
± 26.6
Treated, Psychological Aspects
69.9
± 21.7
3-month post radiation
Group
Value
95% CI
Treated, Painful Site
17.7
± 14.4
Treated, Pain Characteristics
18.1
± 16.6
Treated, Functional Interference
74.8
± 21.0
Treated, Psychological Aspects
68.1
± 23.3
Change (Last Day of radiation - Pre-radiation)
Group
Value
95% CI
Treated, Painful Site
-6.5
± 14.1
Treated, Pain Characteristics
-6.2
± 19.4
Treated, Functional Interference
9.8
± 18.7
Treated, Psychological Aspects
7.4
± 18.7
Change (1-month post radiation - Pre-radiation)
Group
Value
95% CI
Treated, Painful Site
-9.4
± 15.7
Treated, Pain Characteristics
-9.0
± 25.9
Treated, Functional Interference
10.5
± 29.8
Treated, Psychological Aspects
9.0
± 17.1
Change (3-month post radiation - Pre-radiation)
Group
Value
95% CI
Treated, Painful Site
-10.7
± 15.8
Treated, Pain Characteristics
-13.7
± 20.0
Treated, Functional Interference
11.9
± 23.1
Treated, Psychological Aspects
6.7
± 19.0
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)Secondary· 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 fun
Pre-radiation
Group
Value
95% CI
Evaluable, Global Health
72.7
± 19.6
Evaluable, Pain
42.6
± 28.9
Last Day of radiation
Group
Value
95% CI
Evaluable, Global Health
68.1
± 20.5
Evaluable, Pain
32.4
± 28.4
1-month post radiation
Group
Value
95% CI
Evaluable, Global Health
72.7
± 20.4
Evaluable, Pain
28.7
± 23.8
3-month post radiation
Group
Value
95% CI
Evaluable, Global Health
71.9
± 20.5
Evaluable, Pain
28.6
± 23.8
Change (Last Day of radiation - Pre-radiation)
Group
Value
95% CI
Evaluable, Global Health
-4.6
± 21.3
Evaluable, Pain
-10.2
± 25.3
Change (1-month post radiation - Pre-radiation)
Group
Value
95% CI
Evaluable, Global Health
0.0
± 22.9
Evaluable, Pain
-13.9
± 27.7
Change (3-month post radiation - Pre-radiation)
Group
Value
95% CI
Evaluable, Global Health
-0.5
± 19.6
Evaluable, Pain
-13.8
± 26.0
Depression as Measured by Hospital Anxiety and Depression Scale (HADS)Secondary· 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
Pre-radiation
Group
Value
95% CI
Evaluable Depression
4.9
± 3.5
Evaluable Anxiety
6.1
± 3.6
Last day of radiation
Group
Value
95% CI
Evaluable Depression
4.6
± 3.5
Evaluable Anxiety
5.3
± 3.8
1-month post radiation
Group
Value
95% CI
Evaluable Depression
4.3
± 3.5
Evaluable Anxiety
5.2
± 3.6
3-month post radiation
Group
Value
95% CI
Evaluable Depression
4.1
± 3.5
Evaluable Anxiety
5.3
± 4.0
Change (Last day of radiation - Pre-radiation)
Group
Value
95% CI
Evaluable Depression
-0.3
± 2.0
Evaluable Anxiety
-0.8
± 1.9
Change (1-month post radiation - Pre-radiation)
Group
Value
95% CI
Evaluable Depression
-0.6
± 2.6
Evaluable Anxiety
-0.8
± 2.3
Change (3-month post radiation - Pre-radiation)
Group
Value
95% CI
Evaluable Depression
-0.7
± 3.5
Evaluable Anxiety
-0.8
± 3.0
Number of Participants With Adherence as Measured by Drug DiarySecondary· 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
Adherence will be determined by number of days drug taken divided by number of days drug should have been taken over the time period of the study.
Pre-radiation
Group
Value
95% CI
Evaluable Palbo
36
Evaluable Hormone
36
Last Day of radiation
Group
Value
95% CI
Evaluable Palbo
33
Evaluable Hormone
35
1-month post radiation
Group
Value
95% CI
Evaluable Palbo
25
Evaluable Hormone
29
3-month post radiation
Group
Value
95% CI
Evaluable Palbo
26
Evaluable Hormone
30
Adverse events — posted to ClinicalTrials.gov
Time frame: All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Grade 1 Adverse Event
Serious: 0/36 (0%)
Deaths: 0/36
Grade 2 Adverse Event
Serious: 0/36 (0%)
Deaths: 0/36
Grade 3 Adverse Event
Serious: 0/36 (0%)
Deaths: 0/36
Grade 4 Adverse Event
Serious: 0/36 (0%)
Deaths: 0/36
Grade 5 Adverse Event
Serious: 0/36 (0%)
Deaths: 7/36
Other adverse events (31 terms — click to expand)
Reaction
System
Grade 1 Adverse Event
Grade 2 Adverse Event
Grade 3 Adverse Event
Grade 4 Adverse Event
Grade 5 Adverse Event
White Blood Cell Decrease
Investigations
—
—
—
—
—
Neutrophil Count Decrease
Blood and lymphatic system disorders
—
—
—
—
—
Anemia
Blood and lymphatic system disorders
—
—
—
—
—
Fatigue
General disorders
—
—
—
—
—
Lymphocyte Count Decrease
Blood and lymphatic system disorders
—
—
—
—
—
Platelet Count Decreased
Investigations
—
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
—
Diarrhea
Gastrointestinal disorders
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
Anorexia
General disorders
—
—
—
—
—
Moderate erythema over sternum
Skin and subcutaneous tissue disorders
—
—
—
—
—
Any Grade 4 AE - excluding neutropenia and leukpenia
This phase II trial studies how well radiation therapy given with standard care palbociclib and hormone therapy work in treating patients with breast cancer that has spread from one part of the body to the bone. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Antihormone therapy, such as fulvestrant, letrozole, anastrozole, exemestane, or tamoxifen, may lessen the amount of estrogen made by the body. Giving radiation therapy, palbociclib, and hormone therapy may work better in treating breast cancer patients with bone metastasis.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07391774 — Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribocic
· Phase 3
· not yet recruiting
NCT06905301 — Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and W
· recruiting
NCT06930859 — Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Recepto
· recruiting
NCT06223698 — Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer
· Phase 3
· not yet recruiting
NCT06671912 — Testing Low Dose Tamoxifen for Invasive Breast Cancer, the (LoTam) Trial
· Phase 3
· suspended
Other recruiting trials for Anatomic Stage IV Breast Cancer AJCC v8
Currently open trials in the same condition.
NCT07137416 — Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for H
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· recruiting
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· Phase 2
· recruiting
NCT07078604 — A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negati
· Phase 2
· recruiting
NCT06434064 — Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advan
· Phase 2
· recruiting
NCT06502691 — [18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Ca
· Phase 1, PHASE2
· recruiting
Other Emory University trials
Trials by the same sponsor.
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· NA
· withdrawn
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· NA
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NCT07405476 — Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative I
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 17 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03691493.