Know Cancer

or
forgot password

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]


Phase 3
18 Years
45 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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]


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

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

Principal Investigator

Lucia Del Mastro, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Institute for Cancer Research, Italy

Authority:

United States: Federal Government

Study ID:

GIM-6

NCT ID:

NCT00311636

Start Date:

September 2003

Completion Date:

April 2008

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms

Name

Location