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Second line chemotherapy

Phase 2

Breast Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Jun 21, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment114

FDA Designations

No designations recorded

Clinical trial landscape

Second line chemotherapy · 1 trial · 1 indication

Phase 2 1
NCT00444587A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.Breast Cancer
COMPLETED114 Analytics
PHASE2COMPLETED
A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Median Time to Disease Progression
Up to 5 years

Time to disease progression (TTP) in days was defined as the time from enrollment to objective disease progression (all categories other than objective disease progression was set to be censored including death before progression). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Tumor assessments were performed using computer tomography or magnetic resonance imaging. TTP as assessed by investigator, along with a recalculation done by computer algorithm is presented below. Median time was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.

Secondary Endpoints

Objective Response Rate
Up to 5 years
Clinical Benefit Rate
Up to 5 years
Median Time to Treatment Failure
Up to 5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Trastuzumab + 2nd Line ChemotherapyEXPERIMENTAL -
Only ChemotherapyACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Second line chemotherapyDRUGAs prescribed
trastuzumab [Herceptin]DRUG6mg/kg iv every 3 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: * female patients, \>= 18 years of age; * metastatic breast cancer; * HER2 overexpression (IHC 3+ and/or FISH positive); * disease progression during or after previous 1st line chemotherapy + Herceptin; * scheduled to receive 2nd line chemotherapy. Exclusion Criteria: * concur...

Countries:BulgariaEstoniaHungaryIsraelLithuaniaNorth MacedoniaSlovakiaTurkey (Türkiye)
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Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 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
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, 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.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about Second line chemotherapy

What is Second line chemotherapy used for?

Second line chemotherapy is used for treating Breast Cancer and Non-Squamous Non-Small Cell Lung Cancer. It is an oncology treatment developed by Roche Holding AG. The drug is currently in Phase 2 clinical development for these indications.

Who makes Second line chemotherapy?

Second line chemotherapy is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's effectiveness in treating certain types of cancer.

What phase is Second line chemotherapy in?

Second line chemotherapy is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its potential use in treating Breast Cancer and Non-Squamous Non-Small Cell Lung Cancer.

What clinical trials is Second line chemotherapy in?

Second line chemotherapy has been studied in clinical trials including NCT00444587, a Phase 2 study of Herceptin in combination with 2nd-line chemotherapy in HER2 positive metastatic breast cancer patients, and NCT01328951, a Phase 3 study of erlotinib in advanced non-small cell lung cancer. Both trials are completed.

Is Second line chemotherapy the same as Herceptin?

Second line chemotherapy is not the same as Herceptin. Herceptin is a specific drug used in combination with second-line chemotherapy in a clinical trial for HER2 positive metastatic breast cancer. Second line chemotherapy refers to the treatment regimen given after initial therapy has not worked.