Know Cancer

or
forgot password

Preservation of Ovarian Function in Young Women Treated With (Neo) Adjuvant Chemotherapy for Breast Cancer: A Randomized Trial Using the Gonadotropin-releasing Hormone (GnRH) Agonist (Triptorelin) During Chemotherapy


Phase 2
N/A
44 Years
Not Enrolling
Female
Breast Cancer, Hormone Changes, Drug Toxicity

Thank you

Trial Information

Preservation of Ovarian Function in Young Women Treated With (Neo) Adjuvant Chemotherapy for Breast Cancer: A Randomized Trial Using the Gonadotropin-releasing Hormone (GnRH) Agonist (Triptorelin) During Chemotherapy


OBJECTIVES:

Primary

- Determine the protective effect of chemical ovarian suppression using triptorelin on
the preservation of ovarian function in premenopausal women with early-stage operable
breast cancer undergoing adjuvant or neoadjuvant systemic chemotherapy.

Secondary

- Determine the rate of chemotherapy-related amenorrhea in patients treated with this
drug.

- Determine the value of inhibin A and B as alternative markers of premature ovarian
failure in patients treated with this drug.

- Determine quality of life of patients treated with this drug.

- Determine disease-free and overall survival of patients treated with this drug.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(< 35 years vs 35 to 39 years vs > 39 years); concurrent neoadjuvant or adjuvant systemic
chemotherapy (fluorouracil, epirubicin, and cyclophosphamide [6 courses] OR fluorouracil,
doxorubicin, and cyclophosphamide [6 courses] vs doxorubicin and cyclophosphamide [AC] [4
courses] vs doxorubicin and cyclophosphamide [AC] [4 courses] followed by a taxane [4
courses]); and hormone receptor status (estrogen receptor [ER]- AND progesterone receptor
[PR]-negative vs ER- OR PR-positive).

- Arm I: Beginning within 1-4 weeks before the start of chemotherapy, patients receive
triptorelin intramuscularly once monthly for 4-6 months during neoadjuvant or adjuvant
systemic chemotherapy.

- Arm II: Patients receive neoadjuvant or adjuvant systemic chemotherapy only. Quality of
life is assessed at baseline, monthly during treatment, every 6 months for 2 years, and
then annually for 3 years.

Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 138 patients (69 per treatment arm) will be accrued for this
study within 35 months.


Inclusion Criteria:



DISEASE CHARACTERISTICS:

- Histologically confirmed breast cancer

- Early-stage, operable disease

- Scheduled to receive adjuvant or neoadjuvant systemic chemotherapy for breast cancer

- Hormone receptor status:

- Meets 1 of the following criteria:

- Estrogen receptor (ER)- OR progesterone receptor (PR)-positive

- ER- AND PR-negative

- No history of premature ovarian failure

PATIENT CHARACTERISTICS:

Age

- Under 45

Sex

- Female

Menopausal status

- Premenopausal

- Follicle-stimulating hormone levels < 40 IU/L at baseline AND at least 2
menstrual periods within the past 6 months

- No first-degree relative menopausal at < 40 years of age

Performance status

- Eastern Cooperative Oncology Group [ECOG] 0-1

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- Not pregnant or nursing

- Fertile patients must use effective non-hormonal methods of contraception

- No prior osteoporosis or other non-malignant systemic disease that would preclude
prolonged follow-up

- No known allergies to gonadotrophin-releasing hormone agonists

- No other cancer except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- No prior chemotherapy

Endocrine therapy

- At least 2 weeks since prior oral contraceptives

- No prior fertility treatment

- Clomiphene or pergonal for polycystic ovarian disease allowed

- No other concurrent oral or transdermal hormonal therapy, including any of the
following:

- Estrogen

- Progesterone

- Androgens

- Aromatase inhibitors

- Hormone replacement therapy

- Oral contraceptives

Radiotherapy

- No prior ovarian radiotherapy

Surgery

- No prior bilateral oophorectomy

- No plans for oophorectomy or hysterectomy within the next 2 years

Other

- At least 1 week since prior warfarin

Exclusion Criteria:

- History of premature ovarian failure

- Over 45 years of age

- First-degree relative menopausal at < 40 years of age

- Pregnant or nursing

- Prior osteoporosis or other non-malignant systemic disease that would preclude
prolonged follow-up

- Known allergies to gonadotrophin-releasing hormone agonists

- Other cancer besides nonmelanoma skin cancer

- Prior chemotherapy

- Prior ovarian radiotherapy

- Prior bilateral oophorectomy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Time to Resumption of Menses

Outcome Description:

Ovarian function as assessed by follicle stimulating hormone (FSH) and record of menses every 6 months beginning in month 6 for 2 years and then annually for 3 years

Outcome Time Frame:

Baseline, end of chemotherapy then 5 years

Safety Issue:

No

Principal Investigator

Pamela N. Munster, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000374991

NCT ID:

NCT00090844

Start Date:

July 2004

Completion Date:

May 2008

Related Keywords:

  • Breast Cancer
  • Hormone Changes
  • Drug Toxicity
  • drug/agent toxicity by tissue/organ
  • hormone changes
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms
  • Drug Toxicity

Name

Location

CCOP - MeritCare HospitalFargo, North Dakota  58122
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Scott and White HospitalTemple, Texas  76508
CCOP - NorthwestTacoma, Washington  98405-0986
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
MBCCOP - JHS Hospital of Cook CountyChicago, Illinois  60612