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Endocrine therapy for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dana Farber Cancer Institute, Boston, MABreast CancerEndocrine therapy - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial looks at the safety of using abemaciclib in different combinations of drugs to treat breast cancer that has spread.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Take of Pounds Sensibly (TOPS)
1
AC682
1
Part 3 (Single dose): Participants receiving VH4004280 (new formulation)

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Baseline to study completion (estimated as 12 months)

Month 12
Number of Participants with One or More Drug-Related Adverse Events
Month 12
Number of Participants with a Complete or Partial Tumor Response (Overall Response Rate)
Month 12
Change in MD Anderson Symptom Inventory (MDASI) Score from Baseline
Day 28
Pharmacokinetics: Area under the Curve (AUC) of LY2835219, Letrozole, Anastrozole, Tamoxifen, Exemestane, Everolimus, Trastuzumab, LY3023414, Fulvestrant, and Pertuzumab
Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219, Letrozole, Anastrozole, Tamoxifen, Exemestane, Everolimus, Trastuzumab, LY3023414, Fulvestrant, and Pertuzumab
Month 12
Progression Free Survival (PFS)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Take of Pounds Sensibly (TOPS)
1
AC682
1
Part 3 (Single dose): Participants receiving VH4004280 (new formulation)

Trial Design

13 Treatment Groups

LY3023414 + LY2835219 + Fulvestrant Dose Escalation
1 of 13
LY2835219+ Trastuzumab Dose Expansion
1 of 13
LY2835219 + Exemestane
1 of 13
LY3023414 + LY2835219 + Fulvestrant Dose Expansion
1 of 13
LY2835219 + Letrozole
1 of 13
LY2835219 + Exemestane + Everolimus Dose Escalation
1 of 13
LY2835219 + Tamoxifen
1 of 13
LY2835219 + Exemestane + Everolimus Dose Expansion
1 of 13
LY2835219 + Anastrozole
1 of 13
LY2835219 + Endocrine Therapy
1 of 13
LY2835219 +Trastuzumab +Pertuzumab +Loperamide Dose Escalation
1 of 13
LY2835219+ Trastuzumab Dose Escalation
1 of 13
LY2835219 +Trastuzumab + Pertuzumab +Loperamide Dose Expansion
1 of 13

Experimental Treatment

198 Total Participants · 13 Treatment Groups

Primary Treatment: Endocrine therapy · No Placebo Group · Phase 1

LY3023414 + LY2835219 + Fulvestrant Dose EscalationExperimental Group · 3 Interventions: LY3023414, LY2835219, Fulvestrant · Intervention Types: Drug, Drug, Drug
LY2835219+ Trastuzumab Dose ExpansionExperimental Group · 2 Interventions: LY2835219, Trastuzumab · Intervention Types: Drug, Drug
LY2835219 + ExemestaneExperimental Group · 2 Interventions: LY2835219, Exemestane · Intervention Types: Drug, Drug
LY3023414 + LY2835219 + Fulvestrant Dose ExpansionExperimental Group · 3 Interventions: LY3023414, LY2835219, Fulvestrant · Intervention Types: Drug, Drug, Drug
LY2835219 + LetrozoleExperimental Group · 2 Interventions: LY2835219, Letrozole · Intervention Types: Drug, Drug
LY2835219 + Exemestane + Everolimus Dose EscalationExperimental Group · 3 Interventions: Everolimus, LY2835219, Exemestane · Intervention Types: Drug, Drug, Drug
LY2835219 + TamoxifenExperimental Group · 2 Interventions: LY2835219, Tamoxifen · Intervention Types: Drug, Drug
LY2835219 + Exemestane + Everolimus Dose ExpansionExperimental Group · 3 Interventions: Everolimus, LY2835219, Exemestane · Intervention Types: Drug, Drug, Drug
LY2835219 + AnastrozoleExperimental Group · 2 Interventions: LY2835219, Anastrozole · Intervention Types: Drug, Drug
LY2835219 + Endocrine TherapyExperimental Group · 2 Interventions: LY2835219, Endocrine therapy · Intervention Types: Drug, Drug
LY2835219 +Trastuzumab +Pertuzumab +Loperamide Dose EscalationExperimental Group · 4 Interventions: LY2835219, Trastuzumab, Loperamide, Pertuzumab · Intervention Types: Drug, Drug, Drug, Drug
LY2835219+ Trastuzumab Dose EscalationExperimental Group · 2 Interventions: LY2835219, Trastuzumab · Intervention Types: Drug, Drug
LY2835219 +Trastuzumab + Pertuzumab +Loperamide Dose ExpansionExperimental Group · 5 Interventions: LY2835219, Endocrine therapy, Trastuzumab, Loperamide, Pertuzumab · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY-3023414
Not yet FDA approved
Everolimus
FDA approved
Abemaciclib
FDA approved
Letrozole
FDA approved
Fulvestrant
FDA approved
Endocrine therapy
2019
Completed Phase 3
~35350
Tamoxifen
FDA approved
Exemestane
FDA approved
Anastrozole
FDA approved
Trastuzumab
FDA approved
Loperamide
FDA approved
Pertuzumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to study completion (estimated as 12 months)

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,482 Previous Clinical Trials
3,142,948 Total Patients Enrolled
63 Trials studying Breast Cancer
36,818 Patients Enrolled for Breast Cancer
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,268 Previous Clinical Trials
371,099 Total Patients Enrolled
21 Trials studying Breast Cancer
10,612 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · Female Participants · 18 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

What medical conditions are Endocrine therapies most often prescribed for?

"Endocrine therapy, which is used to target estrogen receptors, has the potential to combat a range of illnesses such as disease progression, diarrhea, and pulmonary issues." - Anonymous Online Contributor

Unverified Answer

Are there vacancies currently available for participants of this research?

"At present, this trial is not open for enrollment. The study was first made available on March 10th 2014 and last updated August 8th 2022; however, if you are looking for other clinical trials there are 2287 studies focusing on breast cancer that are still accepting patients and 613 endocrine therapy related experiments." - Anonymous Online Contributor

Unverified Answer

Have any prior experiments been conducted related to Endocrine treatment?

"Endocrine therapy was initially examined in 1994 at Queen Mary University of London. Since then, a total of 1272 trials have been finished, and 613 are presently active - notably there is a high concentration of research conducted out of Nashville, Tennessee." - Anonymous Online Contributor

Unverified Answer

At which locations is this research experiment being conducted?

"Patients in need of this medical intervention can be enrolled at Tennessee Oncology PLLC, Providence Cancer Center Oncology Hematology Care and University of North Carolina at Chapel Hill. Additionally, there are 16 other enrolment sites across the United States." - Anonymous Online Contributor

Unverified Answer

Has Endocrine therapy received authorization from the FDA yet?

"We gave endocrine therapy a score of 1 on our scale, indicating that while it has been trialled before, there is limited evidence to support its efficacy and safety." - Anonymous Online Contributor

Unverified Answer

To what extent is this experiment being conducted with participants?

"At this time, no patients are being enrolled in the trial. The study was initially released on March 10th 2014 and has since been updated as recently as August 8th 2022. However, if you wish to explore alternative options for participation there are currently 2287 studies actively seeking out individuals with breast cancer and 613 endocrine therapy trials looking for participants." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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