18 and older, female only, with Breast Cancer Stage IV or Unresectable Locally Advanced Invasive Breast Cancer. 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.
Clinical Benefit RatePrimary· Assessed for response for up to 34 months
Clinical Benefit Rate is the percentage of participants who achieve clinical benefit from the study treatment. Clinical benefit is defined as at least 24 weeks of confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
SD or better is achieved if the following are true:
Target Lesions:
-At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of a
Group
Value
95% CI
Palbociclib in Combination With Bazedoxifene
33
9.8 – 56.4
Clinical Benefit Rate by ESR1 GenotypePrimary· Assessed for response for up to 34 months
Clinical Benefit Rate is the percentage of participants who achieve clinical benefit from the study treatment. Clinical benefit is defined as at least 24 weeks of confirmed CR, PR, SD.
SD or better is achieved if the following are true:
Target Lesions:
-At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is 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.
Non-target Lesions:
* No progression.
* No
Wild Type
Group
Value
95% CI
Palbociclib in Combination With Bazedoxifene
31
11.0 – 58.67
Mutant
Group
Value
95% CI
Palbociclib in Combination With Bazedoxifene
43
9.9 – 81.6
Percent of Participants With All Grade Neutrophil Count DecreasePrimary· Baseline, until resolution or for 30 days after the subject's last study visit, up to 43 months.
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 regardless of whether the event is related or unrelated to treatment. Neutrophil counts are evaluated using established methods.
Group
Value
95% CI
Palbociclib in Combination With Bazedoxifene
61.1
45 – 77
Number of Participants With All Grade Neutrophil Count DecreaseSecondary· Baseline, until resolution or for 30 days after the subject's last study visit, up to 43 months.
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 regardless of whether the event is related or unrelated to treatment. Neutrophil counts are evaluated using established methods.
Group
Value
95% CI
Palbociclib in Combination With Bazedoxifene
22
Objective Response RateSecondary· Assessed for response for up to 34 months
The objective response rate is the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria.
PR or better is achieved if the following are true:
Target Lesions:
-At least a 30% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is 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.
Non-target
Group
Value
95% CI
Palbociclib in Combination With Bazedoxifene
11.1
3.1 – 26.4
Median Progression-Free SurvivalSecondary· Up to 42 months
Progression free survival (PFS) is defined as the time from start of treatment to disease progression or death from any cause as estimated by Kaplan Meier methods. Progression is measured using RECIST 1.1 criteria, defined as at least a 20% increase in size in target lesion and/or unequivocal progression of non-target lesions and/or appearance of new lesions. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free.
Group
Value
95% CI
Palbociclib in Combination With Bazedoxifene
3.58
1.97 – 7.24
Median Overall SurvivalSecondary· Up to 42 months
Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.
Group
Value
95% CI
Palbociclib in Combination With Bazedoxifene
26.5
1.5 – 41.5
Median Progression-Free Survival for Patients by ESR1 GenotypeSecondary· Up to 24 months
Progression free survival (PFS) is defined as the time from start of treatment to disease progression or death from any cause as estimated by Kaplan Meier methods. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free. ESR1 genotype is determined using established methods. Progression is measured using RECIST 1.1 criteria, defined as at least a 20% increase in size in target lesion and/or unequivocal progression of non-target lesions and/or appearance of new lesions
Mutant
Group
Value
95% CI
Palbociclib in Combination With Bazedoxifene
2.0
1.5 – 9.3
Wild Type
Group
Value
95% CI
Palbociclib in Combination With Bazedoxifene
3.6
1.9 – 5.7
Overall Survival by ESR1 GenotypeSecondary· Up to 42 months
Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. ESR1 genotype determined by established methods.
Wild Type
Group
Value
95% CI
Palbociclib in Combination With Bazedoxifene
21.1
13.2 – NA
Mutant
Group
Value
95% CI
Palbociclib in Combination With Bazedoxifene
26.5
1.5 – NA
Objective Response Rate by ESR1 GenotypeSecondary· Up to 34 months
The objective response rate is the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria.
PR or better is achieved if the following are true:
Target Lesions:
-At least a 30% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is 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.
Non-target
Wild Type
Group
Value
95% CI
Palbociclib in Combination With Bazedoxifene
0
Palbociclib in Combination With Bazedoxifene
0
Palbociclib in Combination With Bazedoxifene
13
Palbociclib in Combination With Bazedoxifene
5
Mutant
Group
Value
95% CI
Palbociclib in Combination With Bazedoxifene
0
Palbociclib in Combination With Bazedoxifene
0
Palbociclib in Combination With Bazedoxifene
3
Palbociclib in Combination With Bazedoxifene
5
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline, until resolution or for 30 days after the subject's last study visit, up to 43 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This research study is studying a drug called Palbociclib in combination with Bazedoxifene (a type of endocrine therapy, which prevents breast cancer cell growth by blocking estrogen stimulation) as a possible treatment for this diagnosis.
The names of the study interventions involved in this study are:
* Palbociclib
* Bazedoxifene
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer
· Phase 3
· not yet recruiting
NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
· Phase 3
· recruiting
NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated,
· recruiting
NCT07123090 — A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
· Phase 2
· recruiting
NCT06997029 — A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
· Phase 1
· recruiting
Other recruiting trials for Breast Cancer Stage IV
Currently open trials in the same condition.
NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term
· Phase 2
· recruiting
NCT07371585 — Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management
· Phase 2
· recruiting
NCT06830382 — HER2-PET as a Precision Imaging Tool for Treatment With HER2-ADC in HER2-expressing mBC
· recruiting
NCT06889688 — Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast
· Phase 3
· active not recruiting
NCT06678269 — A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer
· Phase 1
· recruiting
Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
NCT07519200 — Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
· NA
· not yet recruiting
NCT07499999 — Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk fo
· Phase 2
· not yet recruiting
NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO)
· NA
· not yet recruiting
NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
· NA
· not yet recruiting
NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)
· Phase 2
· not yet recruiting
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 Dana-Farber Cancer Institute
Last refreshed: 24 October 2022
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/NCT02448771.