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Epirubicin

Phase 2

Neoadjuvant Operable Breast Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Mar 15, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment125

FDA Designations

No designations recorded

Clinical trial landscape

Epirubicin · 1 trial · 1 indication

Phase 2 1
NCT02400567Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal WomenNeoadjuvant Operable Breast Cancer
COMPLETED125 Analytics
PHASE2COMPLETED
Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women
Neoadjuvant Operable Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluation of the number of patients with a Residual Cancer Burden (RCB) 0-I index as a measure of efficacy
21 weeks

Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 6 variables are included in a calculation formula.

Secondary Endpoints

Evaluation of the clinical response in each treatment arm as defined by clinical and ultrasound examination.
21 weeks
Determination of the number and type of Adverse Events as a Measure of Safety and Tolerability
21 weeks
Correlation of the PAM50 risk of recurrence (ROR) score to its ability to predict RCB as defined in outcome 1
21 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ChemotherapyACTIVE_COMPARATOR3 cycles of FEC 100 followed by 3 cycles of Docetaxel Drugs: Fluorouracile, Epirubicine, Cyclophosphamide, Docetaxel
Letrozole PalbociclibEXPERIMENTALDrugs: letrozole + palbociclib combination

Interventions

NameTypeDescription
FluorouracileDRUG -
EpirubicinDRUG -
CyclophosphamideDRUG -
LetrozoleDRUG -
PalbociclibDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Aged ≥ 18 years, Post-menopausal women 2. Newly diagnosed and operable unilateral invasive breast cancer, not candidate or uncertain for breast conservation - Note: Multicentric/multifocal tumors are allowed provided a maximum of 3 lesions are present, and all share the same ...

Countries:France
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Frequently asked questions about Epirubicin

What is Epirubicin used for in neoadjuvant operable breast cancer?

Epirubicin is a small molecule oncology drug being studied for use in neoadjuvant operable breast cancer. It is being evaluated in postmenopausal women with stage II-IIIA luminal breast cancer as part of a combination treatment approach. The drug is currently in Phase 2 clinical development.

Who makes Epirubicin?

Epirubicin is being developed by Pfizer, Inc., which trades under the ticker symbol PFE on the New York Stock Exchange. The company is conducting clinical research on the drug for the treatment of neoadjuvant operable breast cancer.

What phase is Epirubicin in?

Epirubicin is currently in Phase 2 clinical development for neoadjuvant operable breast cancer. It is an investigational drug and has not yet been approved for this indication. One Phase 2 clinical trial has been completed to evaluate its efficacy and safety.

What clinical trials is Epirubicin in?

Epirubicin has been studied in one completed Phase 2 clinical trial, identified as NCT02400567. This trial evaluated the efficacy of a combination treatment including Epirubicin in postmenopausal women with stage II-IIIA luminal breast cancer. The trial enrolled 125 participants and was conducted in France.

Is Epirubicin the same as other breast cancer treatments?

Epirubicin is a distinct drug being studied for neoadjuvant operable breast cancer. It is being evaluated in combination with other agents, such as letrozole and palbociclib, in clinical trials. Its specific mechanism of action and molecular targets have not been disclosed in available information.