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PTC+Pertuzumab

Phase 3

Breast Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Mar 29, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment437

FDA Designations

No designations recorded

Clinical trial landscape

PTC+Pertuzumab · 1 trial · 2 indications

Phase 3 1
NCT01996267Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2Breast Cancer
ACTIVE NOT_RECRUITING437 Analytics
PHASE3ACTIVE NOT_RECRUITING
Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of patients with pathological complete response
at week 30

To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancer

Secondary Endpoints

Number of patients with grade >2 adverse events as a measure of safety and tolerability
up to week 35
identify prognostic and predictive biomarkers for pCR
within one year after end of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FEC-T +PertuzumabACTIVE_COMPARATORFluorouracil; 500 mg/m2; day 1 Epirubicine; 90 mg/m2; day 1 Cyclophosphamide; 500 mg/m2; day 1 Trastuzumab; 6 mg/kg (loading dose 8 mg/kg) Pertuzumab; 420 mg (loading dose 840 mg); day 1 Cycle is repeated every 21 days
PTC+PertuzumabACTIVE_COMPARATORPaclitaxel; 80 mg/m2; day 1,8 Trastuzumab; 6 mg/kg (loading dose 8 mg/kg); day 1 Carboplatin; AUC=6; day 1 Pertuzumab; 420 mg (loading dose 840 mg); day 1 Cycle repeated every 21 days

Interventions

NameTypeDescription
PTC+PertuzumabDRUGCycle repeated every 21 days
FEC-T+PertuzumabDRUGCycle is repeated every 21 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Histologically confirmed infiltrating breast cancer * Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan. * Overexpression and/or amplification of HER2 in an invasive component of the core b...

Countries:Netherlands
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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 PTC+Pertuzumab

What is PTC+Pertuzumab used for in breast cancer?

PTC+Pertuzumab is a combination therapy being studied for the treatment of HER2-positive breast cancer. It is administered as neoadjuvant chemotherapy, meaning it is given before surgery to shrink tumors. The therapy is currently in Phase 3 clinical development and is intended for patients with this specific type of breast cancer.

What does PTC+Pertuzumab target?

PTC+Pertuzumab targets HER2, a protein that promotes the growth of cancer cells. Pertuzumab is a monoclonal antibody that binds to the HER2 receptor, while PTC refers to a small molecule component of the combination. This targeted approach is designed to treat HER2-positive breast cancer by interfering with cancer cell signaling.

Who makes PTC+Pertuzumab?

PTC+Pertuzumab is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical trials to evaluate the safety and efficacy of this combination therapy for breast cancer.

What phase is PTC+Pertuzumab in?

PTC+Pertuzumab is currently in Phase 3 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is evaluating the combination as a neoadjuvant treatment for HER2-positive breast cancer, with active but not recruiting status.

What clinical trials is PTC+Pertuzumab in?

PTC+Pertuzumab is being studied in a single Phase 3 clinical trial with the identifier NCT01996267. This trial, titled 'Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2', is being conducted in the Netherlands and has enrolled 437 participants. The study is active but not recruiting, and it is randomized and active-controlled.

Is PTC+Pertuzumab the same as Pertuzumab alone?

No, PTC+Pertuzumab is a combination therapy that includes Pertuzumab as one of its components. While Pertuzumab is a monoclonal antibody targeting HER2, the PTC component adds a small molecule to the regimen. This combination is being investigated specifically for its potential in neoadjuvant treatment of HER2-positive breast cancer.