Palbociclib / Metastatic Breast Cancer / Avelumab · Phase 2 Trial

Palbociclib After CDK and Endocrine Therapy (PACE)

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 trial registration for PACE, a study of palbociclib combined with fulvestrant and avelumab in metastatic breast cancer. No results are posted in this registry record; the study is active but not recruiting, with median follow-up of 12.1 months at database lock. Clinical interpretation cannot be made until efficacy and safety outcomes are published.

What was studied

Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Metastatic Breast Cancer; age from 18 Years. Intervention: Fulvestrant with Palbociclib; Fulvestrant with Palbociclib and Avelumab. Compared with: Fulvestrant — Active Comparator. n = 220. 22 sites: United States.

Key findings

Safety

This is a registry record only; no efficacy or safety results are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 2 interventional trial with planned enrollment of 220 participants studying drug combinations for metastatic breast cancer; results are not reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Progression-Free Survival (PFS), According to RECIST v1.1 Criteria (Investigator Assessment) (assessed at Tumor were assessed every 8 weeks until 24 weeks, then every 12 weeks. The medi…)

DesignPhase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationMetastatic Breast Cancer; age from 18 Years

Sample size220

InterventionFulvestrant with Palbociclib; Fulvestrant with Palbociclib and Avelumab

ComparatorFulvestrant — Active Comparator

Setting22 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment220

PhasePhase 2

Primary outcome measureProgression-Free Survival (PFS) according to RECIST v1.1 criteria

Assessment scheduleEvery 8 weeks until 24 weeks, then every 12 weeks

Median follow-up time at database lock12.1 months (range 1 day to 50.1 months)

Caveats

This is a registry record only; no efficacy or safety results are reported.
Study design details including randomisation, blinding, and control arm structure are not specified in this record.
Primary endpoint results and secondary outcomes are not available; follow-up status and data maturity unknown.
Three drug combinations are listed but allocation and comparison structure are not detailed in the registry text.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional design with defined primary endpoint and assessment schedule.

Directness

strong

Directly examines clinical outcome (PFS) in metastatic breast cancer population.

Consistency

insufficient

Registry record does not report results; no consistency data available.

Risk of bias

insufficient

Registry record does not describe blinding, randomisation method, or study conduct details.

Sample adequacy

moderate

Planned enrollment of 220 participants adequate for Phase 2; actual enrollment status not fully detailed.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT03147287). This is a study registration, not published results. Lead sponsor: Dana-Farber Cancer Institute. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 220 participants (ACTUAL). Conditions: Metastatic Breast Cancer. Interventions: DRUG: Palbociclib; DRUG: Fulvestrant; DRUG: Avelumab. Primary outcome measures: Progression-Free Survival (PFS), According to RECIST v1.1 Criteria (Investigator Assessment) , Tumor were assessed every 8 weeks until 24 weeks, then every 12 weeks. The median PFS follow-up time at database lock was 12.1 months (range 1 day to 50.1 months).. Brief summary: This research study is studying three combinations of drugs as treatments for breast cancer. The drugs involved in this study are: * Fulvestrant * Fulvestrant with Palbociclib * Fulvestrant with Palbociclib and Avelumab

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Dana-Farber Cancer InstitutePalbociclibMetastatic Breast CancerNCT03147287AvelumabFulvestrant