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cabergoline

Phase 1

Recurrent Breast Cancer | Small molecule | Oncology |Sage Therapeutics, Inc.|Last Updated: Sep 17, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

cabergoline · 1 trial · 2 indications

Early Phase 1 1
NCT01730729Cabergoline in Metastatic Breast CancerRecurrent Breast Cancer
COMPLETED20 Analytics
EARLY_PHASE1COMPLETED
Cabergoline in Metastatic Breast Cancer
Recurrent Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Response Rate (ORR) at 2 Months
After 8 weeks (2 cycles) of treament

Overall Response Rate (ORR) is defined as the number of patients that achieved Complete Response (CR) or Partial Response (PR) and will be assessed after 8 weeks (2 cycles) of therapy using CT scan images and RECIST guidelines. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD. Progressive Disease (PD): At least a 20% increase in the sum o the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD since the treatment started

Secondary Endpoints

Progression Free Survival (PFS)
From start of treatment until progression of disease or death
Treatment Toxicity
After every 4 weeks (1 cycle) during treatment for up to 20 cycles and 30 days post last treatment
Change in Within-patient Imaging Measurements at Baseline and After 2 Cycles
At baseline and at 8 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment (cabergoline)EXPERIMENTALPatients receive cabergoline oral (PO) twice weekly for weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Interventions

NameTypeDescription
cabergolineDRUGGiven orally
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients must have histologically confirmed metastatic breast cancer; tissue (a minimum of 3 slides) from the most recent biopsy is required for review and confirmation of eligibility; NOTE: material should ideally be from the metastatic disease, however material from the prim...

Countries:United States
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Competitive Landscape -Breast Cancer 403 trials (matched to "Recurrent Breast Cancer")

Top 20 of 94 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3RLY-2608, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2-endoxifen, goserelin
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Frequently asked questions about cabergoline

What is cabergoline used for in recurrent breast cancer?

Cabergoline is being studied as a treatment for recurrent breast cancer, specifically in patients with stage IV breast cancer. It is an investigational small molecule in Phase 1 clinical development for this oncology indication. The drug has been evaluated in a completed early Phase 1 trial in the United States.

What does cabergoline target?

Cabergoline is a small molecule being developed for recurrent breast cancer. The specific molecular target for this indication has not been disclosed in the available clinical trial information. The drug is being studied in a Phase 1 trial for patients with stage IV breast cancer.

Who is developing cabergoline for breast cancer?

Sage Therapeutics, Inc. (NASDAQ: SAGE) is the developer of cabergoline for recurrent breast cancer. The company is conducting clinical research on this small molecule in the oncology therapeutic area, with a completed early Phase 1 trial in metastatic breast cancer.

What phase is cabergoline in for breast cancer?

Cabergoline is in Phase 1 clinical development for recurrent breast cancer. A completed early Phase 1 trial (NCT01730729) evaluated the drug in 20 female patients with stage IV breast cancer. The drug remains investigational and is not approved for this indication.

What clinical trials has cabergoline been in for breast cancer?

Cabergoline has been studied in one clinical trial, NCT01730729, titled "Cabergoline in Metastatic Breast Cancer." This early Phase 1 trial was completed in the United States and enrolled 20 female patients aged 18 years and older with recurrent or stage IV breast cancer. The trial was uncontrolled and not randomized.

Is cabergoline the same as other breast cancer treatments?

Cabergoline is a distinct small molecule being investigated for recurrent breast cancer. No alternative names for this drug have been reported in the clinical trial data. It is being studied as a monotherapy in an uncontrolled early Phase 1 trial for metastatic breast cancer.