Loading clinical trials...

A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer

A Phase Ib/II Study of Debio 1347 Plus Fulvestrant in Patients With FGFR-Amplified Endocrine Receptor Positive Metastatic Breast Cancer

NCT03344536•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of a phase Ib study is to find out the best or maximum tolerated dose of a medication or combination of medications. Therefore, the purpose of this study is to decide the best dose of the study drug, Debio 1347, that can be given in combination with the standard hormonal drug, fulvestrant. Debio 1347 and fulvestrant could shrink the cancer but it could also cause side effects. This study tells us about the side effects of these drugs when given in this new combination, and how often they occur.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and Females Age \> 18 years
•Written informed consent and authorization obtained from the subject/HIPAAappointed legal representative prior to performing any protocol-related procedures including screening evaluations
•Patients with metastatic histologically or cytologically confirmed invasive breast cancer
•Female patients of postmenopausal status. with metastatic histologically or cytologically confirmed invasive breast cancer.
•Postmenopausal status will be defined as following:
•* Age ≥ 60 years
•* Age \< 60 years and 12 months of amenorrhea plus follicle stimulating hormone and plasma estradiol levels within postmenopausal range by local laboratory assessment in the absence of oral contraceptive pills, hormone replacement therapy, or gonadotropin-releasing hormone (GnRH) agonist or antagonist
•* Prior bilateral oophorectomy
•Pre or perimenopausal women allowed with the addition of goserelin
•ECOG performance status 0 -1
+25 more criteria

Exclusion Criteria

•Prior Fulvestrant for metastatic breast cancer will be allowed for phase 1 portion but not for the phase 2 portion
•History of hypersensitivity to any of the excipients in the Debio 1347 formulation (lactose hydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, sodium lauryl sulfate, and magnesium stearate).
•Other malignancies requiring active treatment in the last 6 months.
•Brain tumors and/or brain metastases unless they are asymptomatic, stable on recent imaging (not dated more than 30 days from the inclusion date), and have not required active treatment in the last 6 months.
•History and/or current evidence of endocrine alteration of calcium-phosphate homeostasis.
•History of myocardial infarction or stroke within 6 months, congestive heart failure greater than NYHA class II, unstable angina pectoris, unexplained recurrent syncope, cardiac arrhythmia requiring treatment or family history of sudden death from cardiacrelated causes.
•Baseline Frederica"s corrected QT (QTcF) interval greater than 470 msec (female) or greater than 450 msec (male), history of congenital long QT syndrome, the presence in the screening ECG of a conduction abnormality that in the opinion of the Investigator would preclude safe participation in this study.
•Concomitant use of a drug with a known risk of QTc prolongation
•Current anticoagulation therapy with therapeutic doses of warfarin (low-dose warfarin ≤ 1mg/day or low molecular-weight heparin are permitted).
•History and or current evidence of ectopic mineralisation/calcification including but not limited to the soft tissue, kidneys, intestine, myocardium and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification.
+20 more criteria

Locations (1)

Memorioal Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

November 10, 2017

Primary Completion Date

August 12, 2021

Completion Date

August 12, 2021

Last Updated

November 25, 2022

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

Fulvestrant

DRUG

Debio 1347

DRUG

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

NCT05673200

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+2 more

View study

RECRUITINGNA

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

NCT05245812

Breast CancerHigh Risk of Breast Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer