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FEC-DocGemzar adjuvant chemotherapy

Phase 3

Breast Neoplasms | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jul 3, 2014

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment3,754

FDA Designations

No designations recorded

Clinical trial landscape

FEC-DocGemzar adjuvant chemotherapy · 1 trial · 1 indication

Phase 3 1
NCT02181101Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-TrialBreast Neoplasms
COMPLETED3,754 Analytics
PHASE3COMPLETED
Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial
Breast NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Disease free survival
5 years

Secondary Endpoints

Overall survival
5 years
Number of adverse events related to cancer therapy observed
5 years
Quality of life
5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AA-BAEXPERIMENTALFEC-DocGemzar adjuvant chemotherapy; zoledronic acid i.v. 5 years
AB-BAEXPERIMENTALFEC-Doc adjuvant chemotherapy; zoledronic acid i.v. 5 years
AA-BBEXPERIMENTALFEC-DocGemzar adjuvant chemotherapy; zoledronic acid i.v. 2 years
AB-BBACTIVE_COMPARATORFEC-Doc adjuvant chemotherapy; zoledronic acid i.v. 2 years

Interventions

NameTypeDescription
FEC-DocGemzar adjuvant chemotherapyDRUG -
FEC-Doc adjuvant chemotherapyDRUG -
Zoledronic acid i.v. 2 yearsDRUG -
Zoledronic acid i.v. 5 yearsDRUG -
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Eligibility Criteria

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

Inclusion Criteria: * Primary epithelial invasive carcinoma of the breast pT1-4, pM0 * Histopathological proof of axillary lymph node metastases (pN1-3) or high risk pN0/NX, defined as: 'pT ≥ 2 or histopathological grade 3 or age ≤ 35 or negative hormone receptor status' * Complete resection the pr...

Countries:Germany
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Frequently asked questions about FEC-DocGemzar adjuvant chemotherapy

What is FEC-DocGemzar adjuvant chemotherapy used for?

FEC-DocGemzar adjuvant chemotherapy is used for breast neoplasms, specifically as an adjuvant treatment for breast cancer. It is being studied in a Phase 3 clinical trial in Germany. The drug is developed by Eli Lilly and Company.

Who makes FEC-DocGemzar adjuvant chemotherapy?

FEC-DocGemzar adjuvant chemotherapy is developed by Eli Lilly and Company, which trades under the ticker LLY. The company is conducting a Phase 3 clinical trial for this adjuvant chemotherapy in breast cancer patients.

What phase is FEC-DocGemzar adjuvant chemotherapy in?

FEC-DocGemzar adjuvant chemotherapy is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed with 3,754 female participants.

What clinical trials is FEC-DocGemzar adjuvant chemotherapy in?

FEC-DocGemzar adjuvant chemotherapy is associated with clinical trial NCT02181101, titled 'Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial'. This Phase 3 trial was completed in Germany and enrolled 3,754 female patients with breast neoplasms.

Is FEC-DocGemzar adjuvant chemotherapy the same as gemcitabine-docetaxel combination?

Yes, FEC-DocGemzar adjuvant chemotherapy is the same as the gemcitabine-docetaxel combination. The clinical trial NCT02181101 studies this combination as adjuvant treatment for breast cancer, along with extended bisphosphonate and surveillance.