Phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer - Prevention Of Early Menopause Study (POEMS)

• Register: EUCTR
• Last refreshed on: 21 December 2021
• Main ID: EUCTR2006-002600-33-HU
• Date of registration: 02/07/2007
• Prospective Registration: Yes
• Primary sponsor: International Breast Cancer Study Group (IBCSG)
• Public title: Phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer - Prevention Of Early Menopause Study (POEMS)
• Scientific title: Phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer - Prevention Of Early Menopause Study (POEMS)
• Date of first enrolment: 08/08/2007
• Target sample size: 416
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002600-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: Without ovarian protection
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Hungary, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
Patient must be premenopausal women with a histologically confirmed diagnosis of operable Stage I, II, or IIIA invasive breast cancer. Patients who have completed surgery must have pathologic Stage I, II or IIIa disease. Patients to be treated in the preoperative setting may be staged clinically but must have operable disease. For the purposes of this study, premenopausal is defined as the presence of cyclic menstrual bleeding within 6 weeks prior to randomization or documentation of FSH and estradiol levels in the premenopausal range.

Patients must have tumors that are both estrogen receptor negative and progesterone receptor negative. The definition of hormone receptor negativity will be that used by the registering institution, with the following exceptions:
a. tumors with > 10% cells staining positive for either ER and/or PR on immunohistochemistry assay will be considered receptor positive
b. tumors with > 3 fm/mg cytosol protein on ligand-binding or EIA assay will be considered receptor positive
Patients with bilateral synchronous invasive breast cancer diagnosed within 1 month of each other are eligible only if both primary tumors are hormone receptor negative.

Patients must be of age 18 or greater and under age 50.

The patient's planned treatment must include 3 to 8 months or cycles of an alkylating agent containing post-operative or pre-operative chemotherapy regimen that can be anthracycline-based or non-anthracycline-based.
Patients must not start the planned chemotherapy prior to registration to S0230.


Patients receiving post-operative chemotherapy must be registered within 84 days after the final surgical procedure required to adequately treat the primary tumor or axilla.



Patient must have a performance status of 0-2 by Zubrod criteria.

All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.


Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cancer or other cancer for which the patient has been disease-free for five years after treatment with curative intent.

Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential must agree to use an effective barrier contraceptive method.

For patients receiving chemotherapy in the pre-operative setting, there must be no intention to give additional chemotherapy in the postoperative setting (i.e., all chemotherapy should be completed prior to surgery).

Patients must not have received prior cytotoxic chemotherapy for this breast cancer
or for any condition.

Patients must not have received estrogens, antiestrogens, selective estrogen receptor modulators, aromatase inhibitors, or hormonal forms of contraception within the past month with the following exceptions: Women under the age of 35 may have had recent use of oral contraceptive pills but these must be discontinued prior to randomization. In addition, for women of all ages, up to two months of hormonal treatment for oocyte collection for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes is permitted provided these treatments are completed prior to randomization. Women using oral contraceptive pills or hormonal treatments for oocyte collection during the month prior to enrollment must have documentation of FSH and estradiol levels in the premenopausal range.





Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Premenopausal women, Early Stage I, II or IIIA, ER-/ PR- Breast Cancer
MedDRA version: 8.1 Level: LLT Classification code 10006190 Term: Breast cancer invasive NOS

Intervention(s)

Trade Name: Zoladex
Product Name: Zoladex
Product Code: not applicable
Pharmaceutical Form: Implant
INN or Proposed INN: Goserelin acetate
CAS Number: 65807-02-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.6-

Primary Outcome(s)

Main Objective: The primary objective of this study is to compare the rate of premature ovarian failure at two years following standard adjuvant or neoadjuvant chemotherapy with or without the addition of ovarian suppression with a LHRH analog during chemotherapy in premenopausal women with early stage, hormone-receptor negative breast cancer.

Secondary Objective: The secondary objectives are to compare rates of ovarian dysfunction at one year and two years following standard adjuvant or neoadjuvant chemotherapy with or without ovarian suppression and to evaluate ovarian reserve in the two groups at one and two years. In addition, this study will describe pregnany and other fertility information in the two groups after treatment and during the five year follow-up period.

Primary end point(s): The primary endpoint is the rate of ovarian failure at 2 years from initiation of chemotherapy. Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months and the presence of FSH in the post-menopausal range.

Secondary ID(s)

2006-002600-33-BE

IBCSG 34-05/ SWOG 0230

Ethics review

Status: Approved
Approval date: 25/07/2007
Contact: