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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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10 December 2019 |
Main ID: |
EUCTR2006-002600-33-BE |
Date of registration:
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23/10/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer
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Scientific title:
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Phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer
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Date of first enrolment:
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16/02/2007 |
Target sample size:
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416 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002600-33 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Hungary
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Italy
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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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
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Intervention(s)
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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-
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Primary Outcome(s)
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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.
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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.
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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.
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Secondary ID(s)
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IBCSG 34-05/ SWOG 0230
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
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Results
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Results available:
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