AzTrials
AzTrials

Breast CancerPhase 3NCT00311636

Triptorelin in Preventing Early Menopause in Premenopausal Women Who Are Receiving Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery

A Phase 3 study testing cyclophosphamide, docetaxel and doxorubicin hydrochloride in people with Breast Cancer, run by Gruppo Italiano Mammella (GIM) at 18 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Chemotherapy may cause early menopause in premenopausal women. Triptorelin may prevent this from happening. PURPOSE: This randomized phase III trial is studying triptorelin to see how well it works in preventing early menopause in premenopausal women who are receiving chemotherapy for stage I, stage II, or… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
cyclophosphamide, docetaxel and doxorubicin hydrochloride
Type of treatment
Surgery or procedure
How many people
280 participants
Where
18 sitesItaly
Study dates
Sep 2003to Apr 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed breast cancer resected at time of original diagnosis
  • Stage I-III disease
  • Candidate for 1 of the following adjuvant chemotherapy regimens:
  • FEC (fluorouracil, epirubicin hydrochloride, and cyclophosphamide) every 21 or 28 days
  • CMF (cyclophosphamide, methotrexate, and fluorouracil) every 28 days
  • A→CMF (doxorubicin hydrochloride followed by CMF)
  • EC→P (epirubicin hydrochloride and cyclophosphamide every 21 days followed by paclitaxel every 21 days)
  • FEC→P (FEC every 21 days followed by paclitaxel every 21 days)
  • EC→D (EC every 21 days followed by docetaxel every 21 days)
  • AC (doxorubicin hydrochloride and cyclophosphamide) every 21 days
  • AC→P (AC every 21 days followed by paclitaxel every 21 days)
  • E→CMF (epirubicin hydrochloride followed by CMF every 28 days)
  • No evidence of metastases or localized or distant recurrence
  • Investigation to exclude metastases required for any suspicious manifestation
  • Premenopausal, defined as the presence of active menstrual cycles or normal menses within six weeks before initiation of chemotherapy
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or adequately treated in situ carcinoma of the cervix
  • No history of noncompliance to medical regimens or patients who are considered potentially unreliable
  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy and/or radiotherapy for cancer or non-neoplastic disease
  • No other concurrent hormonal therapy except for tamoxifen

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Italy18 sites

  • Ospedale Civile

    Castelfranco - TV, 31033

  • Ospedale Sant Anna

    Como, 22100

  • Ospedale Santa Croce

    Cuneo, 12100

  • Azienda Ospedaliera di Firenze

    Florence, 50011

  • Istituto Nazionale per la Ricerca sul Cancro

    Genoa, 16132

  • Presidio Ospedaliero di Livorno

    Livorno, 57100

  • Carlo Poma Hospital

    Mantua, 46100

  • Federico II University Medical School

    Naples, 80131

  • Seconda Universita di Napoli

    Naples, 80131

  • Istituto G. Pascale

    Naples, 81131

  • Ospedale Silvestrini

    Perugia, 06156

  • Ospedale Santa Chiara Pisa

    Pisa, 56126

  • Istituto Regina Elena

    Rome, 00128

  • Ospedale Civile ASL 1

    Sassari, 07100

  • Ospedale SS Trinita

    Sora, 03039

  • Ospedale Treviglio Caravaggio

    Treviglio, 24047

  • Ospedale Maggiore dell' Universita

    Trieste, 34100

  • Universita di Torino

    Turin, 10126

Other trials in Italy

About this study

Official title: Prevention of Chemotherapy-induced Menopause by Temporary Ovarian Suppression With Triptorelin Vs. Control in Young Breast Cancer Patients. A Randomized Phase III Multicenter Study [PROMISE]

RATIONALE: Chemotherapy may cause early menopause in premenopausal women. Triptorelin may prevent this from happening.

PURPOSE: This randomized phase III trial is studying triptorelin to see how well it works in preventing early menopause in premenopausal women who are receiving chemotherapy for stage I, stage II, or stage III breast cancer that has been removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Evaluate the incidence of chemotherapy-induced early menopause in premenopausal women undergoing adjuvant chemotherapy in combination with vs without triptorelin for previously resected stage I-III breast cancer.

Secondary

  • Compare the toxicity of adjuvant chemotherapy and triptorelin vs adjuvant chemotherapy alone.

OUTLINE: This is a prospective, open-label, multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (adjuvant chemotherapy alone): Patients receive adjuvant chemotherapy alone.
  • Arm II (adjuvant chemotherapy and triptorelin): Patients receive adjuvant chemotherapy and triptorelin intramuscularly 1 week before and then every 4 weeks for the duration of chemotherapy. The last dose of triptorelin is given before the last course of chemotherapy.

Patients with hormone-sensitive tumors who resume ovarian function after stopping chemotherapy and triptorelin restart triptorelin until ovarian function is suppressed for 2 years.

Patients undergo menopausal status assessment, using follicle-stimulating hormone, luteinizing hormone, and estradiol as biochemical markers, at baseline and 3, 6, 9, and 12 months after the last course of chemotherapy.

After completion of study treatment, patients are followed at 3, 6, 9, and 12 months.

PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.

Conditions
Breast Cancer
Being tested
cyclophosphamide, docetaxel, doxorubicin hydrochloride, epirubicin hydrochloride, fluorouracil
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chemotherapy-induced early menopause as measured by follicle-stimulating hormone, 17 beta estradiol levels, and menstrual activity resumption at 1 year following the completion of chemotherapy

Secondary outcomes (1)

  1. Toxicity as measured by Common Toxicity Criteria at each chemotherapy course

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2006 (estimated)
  2. Study startSep 2003
  3. Primary completionJan 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00311636
Sponsor's protocol ID
GIM-6
Other IDs
CDR0000468839, GIM-PROMISE, EU-20606, GIM-5104
Status last verified
Apr 2008
First submitted
5 Apr 2006
Last updated
26 Jun 2013
Results posted
No

Publications

  • Del Mastro L, Boni L, Michelotti A, Gamucci T, Olmeo N, Gori S, Giordano M, Garrone O, Pronzato P, Bighin C, Levaggi A, Giraudi S, Cresti N, Magnolfi E, Scotto T, Vecchio C, Venturini M. Effect of the gonadotropin-releasing hormone analogue triptorelin on the occurrence of chemotherapy-induced early menopause in premenopausal women with breast cancer: a randomized trial. JAMA. 2011 Jul 20;306(3):269-76. doi: 10.1001/jama.2011.991.

    PubMed 21771987

  • Lambertini M, Boni L, Michelotti A, Gamucci T, Scotto T, Gori S, Giordano M, Garrone O, Levaggi A, Poggio F, Giraudi S, Bighin C, Vecchio C, Sertoli MR, Pronzato P, Del Mastro L; GIM Study Group. Ovarian Suppression With Triptorelin During Adjuvant Breast Cancer Chemotherapy and Long-term Ovarian Function, Pregnancies, and Disease-Free Survival: A Randomized Clinical Trial. JAMA. 2015 Dec 22-29;314(24):2632-40. doi: 10.1001/jama.2015.17291.

    PubMed 26720025

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cyclophosphamide, docetaxel and doxorubicin hydrochloride in people with Breast Cancer, run by Gruppo Italiano Mammella (GIM) at 18 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chemotherapy-induced early menopause as measured by follicle-stimulating hormone, 17 beta estradiol levels, and menstrual activity resumption at 1 year following the completion of chemotherapy. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00311636, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.

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