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3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.

Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.

Epirubucin 60mg/m2 (only node-positive patients)

Surgery

Raimund Jakesz, MD

Primarily, this clinical investigation compared overall survival and recurrence-free survival in patients with hormone receptor-negative breast cancer treated with pre- and postoperative chemotherapy vs. conventional postoperative treatment.

Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients

A Randomized Phase III Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment Hormone Receptor-negative Breast Cancer Patients

Austrian Breast & Colorectal Cancer Study Group

Docetaxel

Panitumumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

vectibix

fluorouracile

Epirubicine

cyclophosphamide

docetaxel

The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination: "FEC-Taxotere/Vectibix".

Assessment of the Efficacy of the Neoadjuvant Combination: "Chemotherapy-Targeted Therapy" in Breast Cancer.

Phase II Trial Assessing Neoadjuvant Therapy With FEC 100 Followed by Taxotere® (Docetaxel) Plus Vectibix® (Panitumumab) in Patients With Operable, HR and Her-2 Negative Breast Cancer. TVA Study

Centre Jean Perrin

Bone Density Conservation Agents

Paclitaxel

Albumin-Bound Paclitaxel

Ibandronic Acid

Taxol

Xeloda

Ibandronat

Volker Möbus, Prof. Dr.

In the recent AGO-study, a dose-dense and dose-intensified sequence of Epirubicin - Paclitaxel - Cyclophosphamide has shown superior efficacy compared to a conventionally dosed sequence of Epirubicin / Cyclophosphamid and Paclitaxel and was therefore chosen as standard treatment in this study.

The experimental arm of EC-TX combines several strategies: the combination of EC will be administered every 2 weeks as a dose-dense regimen, the combination of TX can also be considered as dose-dense due to the weekly application of paclitaxel. Furthermore there is clinical evidence, that a combination of capecitabine and Paclitaxel provide synergistic effects with improved tumour response. A randomized phase III study could demonstrate a survival benefit of a combination of capecitabine with Docetaxel in patients with metastatic breast cancer. This synergistic effect is probably based on the preclinical observed taxane-mediated up-regulation of thymidine phosphorylase in the tumour cell, which give drive to an increased transformation of capecitabine to its active form 5-Fluorouracil. Apart from this synergy, the EC-TX regimen includes now 4 highly active compounds for the treatment of breast cancer. The total doses of Epirubicin and Paclitaxel are identical in both arms. The dosage of Cyclophosphamide is lower in the experimental arm, which is preferred due to the induction of leukaemia at higher doses of Cyclophosphamide. The duration of both arms with 18 and 20 weeks is nearly similar.

The 2 by 2 factorial design of the trial provides the additional possibility to explore the efficacy of a bisphosphonate as another strategy to further improve the prognosis of node positive breast cancer.

Currently several strategies are under investigation to further improve adjuvant treatment of early node-positive breast cancer. These are combination treatment of drugs with synergistic mode of action, dose-dense application of cytotoxic drugs, dose-intensification and the use of new, non-cytotoxic approaches.

In the recent AGO-study, a dose-dense and dose-intensified sequence of Epirubicin - Paclitaxel - Cyclophosphamide has shown superior efficacy compared to a conventionally dosed sequence of Epirubicin / Cyclophosphamid and Paclitaxel and was therefore chosen as standard treatment in this study.

The experimental arm of EC-TX combines several of the above mentioned strategies: the combination of EC will be administered every 2 weeks as a dose-dense regimen, the combination of TX can also be considered as dose-dense due to the weekly application of paclitaxel. Furthermore there is clinical evidence, that a combination of capecitabine and Paclitaxel provide synergistic effects with improved tumour response. A randomized phase III study could demonstrate a survival benefit of a combination of capecitabine with Docetaxel in patients with metastatic breast cancer. This synergistic effect is probably based on the preclinical observed taxane-mediated up-regulation of thymidine phosphorylase in the tumour cell, which give drive to an increased transformation of capecitabine to its active form 5-Fluorouracil. Apart from this synergy, the EC-TX regimen includes now 4 highly active compounds for the treatment of breast cancer. The total doses of Epirubicin and Paclitaxel are identical in both arms. The dosage of Cyclophosphamide is lower in the experimental arm, which is preferred due to the induction of leukaemia at higher doses of Cyclophosphamide. The duration of both arms with 18 and 20 weeks is nearly similar.

The 2 by 2 factorial design of the trial provides the additional possibility to explore the efficacy of a bisphosphonate as another strategy to further improve the prognosis of node positive breast cancer. As the mechanism of action of cytotoxic drugs and bisphosphonates appear to be independent the factorial design is an adequate statistical model for this trial. Up to now only limited information is available on the potential role of bisphosphonates in this setting and they have all been generated by using the 1st generation bisphosphonate Clodronate. 3rd generation bisphosphonates like ibandronate are much more active, less toxic and their application is more convenient (which is of high importance regarding the long duration of treatment).

Primary aims of this trial are to improve disease-free survival by using the EC-TX regimen and by using ibandronate as adjuvant treatment for 2 years.

A Study to Compare ETC vs. EC-TX and Ibandronate vs. Observation in Patients With Node-positive Primary Breast Cancer (GAIN)

A Phase III Trial to Compare ETC vs, EC-TX and Ibandronate vs. Observation in Patients With Node-positive Primary Breast Cancer (GAIN)

German Breast Group

Bevacizumab

Mitogens

Aromatase Inhibitors

Taxane

Angiogenesis Inhibitors

Growth Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Participants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks.

Participants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks. Participants will also receive concurrent treatment with bevacizumab every 3 weeks for 24 weeks.

Participants will receive aromatase inhibitor therapy at discretion of the investigator for a period of 24 weeks.

Participants will receive aromatase inhibitor therapy at discretion of the investigator and concurrent treatment with bevacizumab for a period of 24 weeks.

Participants will receive aromatase inhibitor therapy, at a dose per investigator discretion, once daily for 24 weeks.

Aromatase Inhibitor

Bevacizumab will be administered at a dose of 15 mg/kg as IV infusion every 3 weeks (or 10 mg/kg every other week in participants receiving weekly paclitaxel), for 24 weeks.

Participants will receive epirubicine at a dose of 100 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.

Participants will receive 5FU at a dose of 600 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.

5-Fluorouracil (5FU)

Participants will receive cyclophosphamide at a dose of 600 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.

Participants will receive paclitaxel at a dose of 80 mg/m\^2 as IV infusion every week for 12 weeks.

Participants will receive docetaxel at a dose of 100 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.

Clinical Trials

This study will evaluate the effect of bevacizumab in combination with chemotherapy or endocrine therapy, as preoperative treatment, in participants with HER2 negative breast cancer. Participants will be randomized to receive either chemotherapy (FEC100: Epirubicine 100 milligrams per square meter \[mg/m\^2\], 5-fluorouracil 600 mg/m\^2, and cyclophosphamide 600 mg/m\^2\] for 12 weeks followed by taxane (paclitaxel/docetaxel) for 12 weeks or endocrine therapy (an aromatase inhibitor\] daily for 24 weeks) with or without bevacizumab (15 milligrams per kilogram \[mg/kg\] as intravenous \[IV\] infusion every 3 weeks up 24 weeks).

A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer

A Multicenter, Randomized, Phase II Clinical Trial to Evaluate the Effect of Avastin in Combination With Neoadjuvant Treatment Regimens on the Molecular and Metabolic Characteristics and Changes in the Primary Tumors With Reference to the Obtained Responses in Patients With Large Primary HER2 Negative Breast Cancers

Percentage of participants with different surgery types (for example, Mastectomy, Tumorectomy/Breast conserving therapy (BCT), and Tumorectomy followed by mastectomy) will be reported.

Norwegian Radium Hospital

Hoffmann-La Roche

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients	NCT00309569	Early Stage Bre...	Cyclophosphamid... Methotrexate Fluorouracil Epirubicin Surgery	18 Years - 80 Years	Austrian Breast & Colorectal Cancer Study Group
Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients	NCT00309569	Early Stage Bre...	Cyclophosphamid... Methotrexate Fluorouracil Epirubicin Surgery	18 Years - 80 Years	Austrian Breast & Colorectal Cancer Study Group
Assessment of the Efficacy of the Neoadjuvant Combination: "Chemotherapy-Targeted Therapy" in Breast Cancer.	NCT00933517	Pathological Re...	vectibix fluorouracile Epirubicine cyclophosphamid... docetaxel	18 Years -	Centre Jean Perrin
A Study to Compare ETC vs. EC-TX and Ibandronate vs. Observation in Patients With Node-positive Primary Breast Cancer (GAIN)	NCT00196872	Breast Cancer	Epirubicine Cyclophosphamid... Taxol Xeloda Ibandronat	18 Years - 65 Years	German Breast Group
A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer	NCT00773695	Breast Cancer	Aromatase Inhib... Bevacizumab Epirubicine 5-Fluorouracil ... Cyclophosphamid... Paclitaxel Docetaxel	18 Years -	Hoffmann-La Roche
Assessment of the Efficacy of the Neoadjuvant Combination: "Chemotherapy-Targeted Therapy" in Breast Cancer.	NCT00933517	Pathological Re...	vectibix fluorouracile Epirubicine cyclophosphamid... docetaxel	18 Years -	Centre Jean Perrin
A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer	NCT00773695	Breast Cancer	Aromatase Inhib... Bevacizumab Epirubicine 5-Fluorouracil ... Cyclophosphamid... Paclitaxel Docetaxel	18 Years -	Hoffmann-La Roche

Spots Global Cancer Trial Database for epirubicine

Every month we try and update this database with for epirubicine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for epirubicine

Every month we try and update this database with for epirubicine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for epirubicine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.