Fulvestrant for Breast

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast+8 More
Fulvestrant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether radiation therapy, palbociclib, and hormone therapy may work better in treating breast cancer patients with bone metastasis.

Eligible Conditions
  • Breast
  • Estrogen Receptors
  • Bone and Bones
  • HER2/Neu Negative
  • Carcinoma
  • Receptors, Progesterone

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: At 3 months post-radiation

At 3 months post-radiation
Response rate
Response rate incorporating BPI and analgesic measures according to International Bone Consensus Guideline Criteria
Month 3
Progression-free survival (PFS)
Month 3
Overall survival (OS)
Month 3
Adherence as measured by drug diary
Depression as measured by Hospital Anxiety and Depression Scale (HADS)
Fatigue as measured by The Multidimensional Fatigue Inventory (MFI)
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Quality of life as measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)
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)
Quality of life as measured by Short Form Health Survey (SF-36)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Anastrozole
13%Fatigue
11%Arthralgia
11%Nausea
8%Musculoskeletal pain
7%Hot flush
6%Back pain
5%Cough
5%Constipation
5%Diarrhoea
4%Vomiting
4%Dyspnoea
3%Urinary tract infection
1%General Physical Health Deterioration
1%Hypercalcaemia
1%Humerus Fracture
1%Pericardial Effusion
1%Vertigo
1%Pain
1%Chest Pain
1%Dizziness
1%Muscular Weakness
1%Urinary Tract Infection
1%Pneumonia
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT00256698) in the Anastrozole ARM group. Side effects include: Fatigue with 13%, Arthralgia with 11%, Nausea with 11%, Musculoskeletal pain with 8%, Hot flush with 7%.

Trial Design

1 Treatment Group

Radiation, palbociclib, hormone therapy
1 of 1
Experimental Treatment

38 Total Participants · 1 Treatment Group

Primary Treatment: Fulvestrant · No Placebo Group · Phase 2

Radiation, palbociclib, hormone therapyExperimental Group · 7 Interventions: Palbociclib, Anastrozole, Fulvestrant, Exemestane, Radiation Therapy, Tamoxifen, Letrozole · Intervention Types: Drug, Drug, Drug, Drug, Radiation, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved
Anastrozole
FDA approved
Fulvestrant
FDA approved
Exemestane
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7080
Tamoxifen
FDA approved
Letrozole
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 3 months post-radiation

Who is running the clinical trial?

PfizerIndustry Sponsor
4,260 Previous Clinical Trials
7,104,927 Total Patients Enrolled
Emory UniversityLead Sponsor
1,501 Previous Clinical Trials
2,677,518 Total Patients Enrolled
Mylin Torres, MDPrincipal Investigator - Emory University
Emory Johns Creek Hospital, Emory Saint Joseph's, Emory University Hospital, Emory University Hospital Midtown
Stanford University School Of Medicine (Medical School)
U Tx-M D Anderson Cancer C (Residency)
3 Previous Clinical Trials
97 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: October 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.