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Gruppo Oncologico Nord Ovest – Mammella Intergruppo (GONO MIG)

Published online by Cambridge University Press:  04 December 2006

Abstract

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Gruppo Oncologico Nord Ovest – Mammella Intergruppo (GONO MIG). Clinical trials include:

  1. Standard CEF versus accelerated CEF as adjuvant chemotherapy in node-positive or high-risk node-negative (T > 2 cm, age <35 years, G3, negative hormone receptors or high TL1 or S-phase) breast cancer. A phase III randomized trial. MIG-1

  2. Epirubicin plus paclitaxel versus cyclophosphamide, epirubicin and 5-fluorouracil as adjuvant chemotherapy in node-positive breast cancer patients. A phase III randomized study. MIG-5

  3. A phase III randomized study of sequential epidoxorubicin plus cyclophosp-amide followed by docetaxel (EC D) versus a combination of 5-fluorouracil, epidoxorubicin and cyclophosp-amide (FEC) as adjuvant treatment of node-negative early breast cancer patients.

  4. A phase III randomized study of EC followed by paclitaxel versus FEC followed by paclitaxel, all given either every 3 or 2 weeks supported by pegfilgrastim, for node-positive breast cancer patients.

  5. Prevention of chemotherapy-induced menopause by temporary ovarian suppression with triptorelin versus control in young breast cancer patients. A randomized phase III multicenter study.

  6. Letrozole adjuvant therapy duration (lead) study: standard versus long treatment. A phase III trial in post-menopausal women with early breast cancer.

Type
Other
Information
Breast Cancer Online , Volume 9 , Supplement S1: AN OVERVIEW OF RECENT AND ONGOING CLINICAL TRIALS FOR BREAST CANCER 4th EDITION , December 2006 , pp. 212 - 222 , e62
Copyright
© 2006 Cambridge University Press

GONO MIG – Contact Details

Country

Italy

Chair

A. Falcone, Ospedali Riuniti, Oncologia Medica, Viale Alfieri 36, 57100 LIVORNO, ITALY. Tel: +39 586 223458 Fax: +39 586 223457, Email:

Principal Investigator

L. Del Mastro, Istituto Nazionale per la Ricerca sul Cancro, Largo R. Benzi 10, 16132 GENOVA, ITALY. Tel: +39 10 5600 666 Fax: +39 10 5600 850 Email:

Statistician and Data Center

P. Bruzzi, Data Center: Servizio Sperimentazioni Cliniche Controllate, Istituto Nazionale per la Ricerca sul Cancro, Largo R. Benzi 10, 16132 GENOVA, ITALY. Tel: +39 10 5737 477 Fax: +39 10 354103, Email:

GONO MIG – Study Details

Title

Standard CEF versus accelerated CEF as adjuvant chemotherapy in node-positive or high-risk node-negative (T > 2 cm, age <35 years, G3, negative hormone receptors or high TL1 or S-phase) breast cancer.

A phase III randomized trial.

MIG-1

Coordinator(s)

M. Venturini, Istituto Nazionale per la Ricerca sul Cancro, Largo R. Benzi 10, 16132 GENOVA, ITALY. Tel: +39 10 5600 898 Fax: +39 10 5600 850, Email:

Summary

  • Closed in June 1997 (opened in November 1992)
  • Target accrual: 1200 patients

Objective

  • To evaluate overall survival and disease-free survival in early breast cancer patients treated with standard CEF or accelerated CEF as adjuvant chemotherapy.

Scheme

Update

  • Closed in June 1997.
  • Patients randomized: 1214.

Related Publications

Dose-Dense Adjuvant Chemotherapy in Early Breast Cancer Patients: Results From a Randomized Trial. J Nat Cancer Inst 2005; 97: 1724–1733.

HER2 expression and efficacy of dose-dense anthracycline containing adjuvant chemotherapy in breast cancer patients. Br J Cancer 2005; 93: 7–14.

Topics

  • Dose densification

Keywords

Dose-dense, chemotherapy

***************************************************

Title

Epirubicin plus paclitaxel versus cyclophosphamide, epirubicin and 5-fluorouracil as adjuvant chemotherapy in node-positive breast cancer patients. A phase III randomized study.

MIG-5

Coordinator(s)

M. Venturini, Divisione di Oncologia Medica I, Istituto Nazionale per la Ricera sul Cancro, Largo Rosanna Benzi 10, 16132 GENOVA, ITALY. Tel: +39 10 5600 898 Fax: +39 10 5600 850, Email:

Summary

  • Opened in November 1996
  • Target accrual: 1000 patients

Objective

  • To evaluate overall survival and disease-free survival in early breast cancer patients treated with epirubicin plus paclitaxel or CEF as adjuvant chemotherapy.

Scheme

Update

  • Closed in January 2001.
  • 1055 patients recruited.

Related Publications

None available

Topics

  • Node-positive breast cancer

Keywords

Adjuvant chemotherapy

***************************************************

Title

A phase III randomized study of sequential epidoxorubicin plus cyclophospamide followed by docetaxel (EC D) versus a combination of 5-fluorouracil, epidoxorubicin and cyclophospamide (FEC) as adjuvant treatment of node-negative early breast cancer patients.

Coordinator(s)

M. Venturini, Divisione di Oncologia Medica I, Istituto Nazionale per la Ricera sul Cancro, Largo Rosanna Benzi 10, 16132 GENOVA, ITALY. Tel: +39 10 5600 898 Fax: +39 10 5600 850, Email:

S. De Placido, Cattedra Oncologia Medica, Dip. Di Endocrinologia ed Oncologia Mol. E Clinica, Universita' degli Studi Federico II, Via S.Pansini 5, 80131 NAPOLI, ITALY. Tel: +39 81 5457281 Fax: +39 81 5466152, Email:

F. Cognetti, Divisione di Oncologia Medica I, Istituto Regina Elena, Viale Regina Elena, 291, 00161 ROMA, ITALY. Tel: +396 52665330 Fax: +396 52665520, Email: ;

Summary

  • Active since 13 November 2003
  • Target accrual: 3000 patients

Objective

  • To compare the disease-free survival (DFS) in patients treated with the sequential EC D regimen to that in patients treated with the FEC regimen.

Scheme

Update

  • Patients randomized: 812 as of 30 September 2006.
  • Study ongoing.

Related Publications

None available

Topics

  • Node-negative breast cancer

Keywords

Adjuvant chemotherapy, taxanes

***************************************************

Title

A phase III randomized study of EC followed by paclitaxel versus FEC followed by paclitaxel, all given either every 3 or 2 weeks supported by pegfilgrastim, for node-positive breast cancer patients.

Coordinator(s)

M. Venturini, Divisione di Oncologia Medica I, Istituto Nazionale per la Ricera sul Cancro, Largo Rosanna Benzi 10, 16132 GENOVA, ITALY. Tel: +39 10 5600 898 Fax: +39 10 5600 850, Email:

S. De Placido, Cattedra Oncologia Medica, Dip. Di Endocrinologia ed Oncologia Mol. E Clinica Universita' degli, Studi Federico II, Via S.Pansini 5, 80131 NAPOLI, ITALY. Tel: +39 81 5457281 Fax: +39 81 5466152, Email:

F. Cognetti, Divisione di Oncologia Medica I, Istituto Regina Elena, Viale Regina Elena 291, 00161 ROMA, ITALY. Tel: +39 6 52665330 Fax: +39 6 52665520, Email: ;

Summary

  • Active since 19 March 2003
  • Target accrual: 2000 patients

Objective

  • To evaluate the efficacy in terms of disease-free survival (DFS) of 5-fluorouracil addition to EC → T regimen and to determine the efficacy of dose-dense chemotherapy.

Scheme

Chemotherapy

  • EC – Epirubicin 90 mg/m2 IV bolus, Cyclophosphamide 600 mg/m2 IV bolus, every 2 or 3 weeks
  • T – Paclitaxel 175 mg/m2 IV 3-hour infusion, every 2 or 3 weeks
  • FEC – Fluorouracil 600 mg/m2 IV bolus, Epirubicin 90 mg/m2 IV bolus, Cyclophosphamide 600 mg/m2 IV bolus, every 2 or 3 weeks
  • Pegfilgrastim 1 vial (6 mg) 24 hours after each cycle of chemotherapy will administered to patients in ARM C and ARM D

Update

  • Closed in July 2006.
  • 2091 patients recruited.

Related Publications

None available

Topics

  • Node-positive breast cancer.

Keywords

Adjuvant chemotherapy, taxanes, dose-dense

***************************************************

Title

Prevention of chemotherapy-induced menopause by temporary ovarian suppression with triptorelin versus control in young breast cancer patients. A randomized phase III multicenter study.

Coordinator(s)

L. D. Mastro, Divisione di Oncologia Medica I, Istituto Nazionale per la Ricera sul Cancro, Largo Rosanna Benzi 10, 16132 GENOVA, ITALY. Tel: +39 10 5600 666 Fax: +39 10 5600 850, Email:

Summary

  • Active since 29 May 2003.
  • Target accrual: 280

Scheme

  • ARM A = Chemotherapy alone
  • ARM B = Chemotherapy + Triptorelin

Update

  • Patients randomized: 177 as of 30 September 2006.
  • Study ongoing.

Related Publications

None available

Topics

  • Fertility and chemotherapy

Keywords

Fertility, drug-induced amenorrhea, chemotherapy

***************************************************

Title

Letrozole adjuvant therapy duration (lead) study: standard versus long treatment. A phase III trial in post-menopausal women with early breast cancer.

Coordinator(s)

L.D. Mastro, Divisione di Oncologia Medica I, Istituto Nazionale per la Ricera sul Cancro, Largo Rosanna Benzi 10, 16132 GENOVA, ITALY. Tel: +39 10 5600 666 Fax: +39 10 5600 850, Email:

S.D. Placido, Cattedra Oncologia Medica, Dip. Di Endocrinologia ed Oncologia Mol. E Clinica Universita' degli, Studi Federico II, Via S.Pansini 5, 80131 NAPOLI, ITALY. Tel: +39 81 5457281 Fax: +39 81 5466152, Email:

F. Cognetti, Divisione di Oncologia Medica I, Istituto Regina Elena, Viale Regina Elena 291, 00161 ROMA, ITALY. Tel: +39 6 52665330 Fax: +39 6 52665520, Email: ;

Summary

  • Active since 6 April 2005
  • Target accrual: 4050 patients

Objective

  • To compare the disease-free survival (DFS) in patients treated with 2/3 years of letrozole to that in patients treated with the 5 years of letrozole after treatment with tam for 2/3 years.

Scheme

Arm A = patients pre-treated with tam for 2/3 years will receive letrozole 2.5 mg/day for 2–3 years. Total duration of early adjuvant endocrine therapy: 5 years

Arm B = patients pre-treated with tam for 2/3 years will receive letrozole 2.5 mg/day for an additional 5 years. Total duration of early adjuvant endocrine therapy: 7 years for patients pre-treated with 2 years of tam and 8 years for patients pre-treated with 3 years of tam

Update

  • Patients randomized: 373 as of 4 October 2006.
  • Study ongoing.

Related Publications

None available

Topics

  • Aromatase inhibitors

Keywords

Adjuvant endocrine therapy, post-menopause, letrozole