A trial comparing the efficacy between the two hormone drugs degarelix and triptorelin in patients having not yet entered the menopause and having not undergone surgery. Additional to each treatment the patients receive letrozole for locally advanced endocrine responsive breast cancer.
- Conditions
- Premenopausal patients with histologically confirmed locally advanced breast cancer and with primary tumor of ER+/PgR+ and HER2 negative or not amplified.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-005326-29-IT
- Lead Sponsor
- International Breast Cancer Study Group (IBCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 51
•Female gender
•Premenopausal status determined locally:
-Estradiol (E2) above 54 pg/mL (or above 198 pmol/l),measured
=14 days prior to randomization
-If estradiol (E2) is =54 pg/mL, but the patient cannot be
regarded as postmenopausal, estradiol testing should be
repeated to confirm eligibility
•Age = 18 years
•Eastern Cooperative Oncology Group Performance Status
(ECOG PS) of 0 or1.
•Histologically confirmed invasive breast cancer:
-Primary tumor greater than 2 cm diameter, measured by clinical
examination and mammography or echography (cT2-4b)
-Any N
-No evidence of metastasis (M0)
•Primary tumor must have ER and PgR >50% of the cells
•Primary tumor must be HER2 negative or not amplified
•Hematopoietic status:
-Absolute neutrophil count = 1.5 × 109/L,
-Platelet count = 100 × 109/L,
-Hemoglobin = 9 g/dL
•Hepatic status:
-Serum total bilirubin = 1.5 × upper limit of normal (ULN). In the
case of known Gilbert’s syndrome, a higher serum total bilirubin
(< 2 × ULN) is allowed
-AST and ALT = 2.5 × ULN
-Alkaline phosphatase = 2.5 × ULN
•Renal status: Creatinine = 1.5 × ULN
•Negative serum pregnancy test, within 2-weeks (preferably 7
days) prior to randomization. Pregnancy test has to be repeated
before treatment start if treatment does not start within 15
days of the previous test.
•The patient must be willing to use effective non-hormonal
contraception (barrier method – condoms, diaphragm – also in
conjunction with spermicidal jelly, or total abstinence) after the
pregnancy test and up to surgery. Oral, injectable, or implant
hormonal contraceptives or medicated IUD are not allowed.
•Prior fertility treatment is allowed but must have been stopped at
least 12 months before randomization
•The patient has completed the baseline patient-reported
symptoms questionnaire
•Written Informed Consent (IC) must be signed and dated by the
patient and the Investigator prior to randomization
•The patient has been informed of and agrees to data transfer
and handling, in accordance with national data protection
guidelines
•The patient accepts blood samples to be taken according to the
schedule in section 4.1 for the determination of the primary
endpoint
•The patient accepts to make tumor (biopsy and surgical
specimen) available for submission for central pathology review
and to conduct translational studies as part of this protocol
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Postmenopausal patients.
•Any hormonal treatment (either oral, injectable, implant, or
medicated IUD) in the previous 2 months.
•Presence of HER2/neu overexpression or amplification.
•Received any prior treatment for primary invasive breast cancer.
•Received any GnRH analog or SERM or AI within 12 months prior
to randomization
• Previous (less than 10 years) or current history of malignant
neoplasms, except for curatively treated:
-Basal and squamous cell carcinoma of the skin
-Carcinoma in situ of the cervix
-Carcinoma in situ of the bladder
•Diagnosis of inflammatory breast cancer
•Bilateral invasive breast cancer
•Known history of uncontrolled or symptomatic angina, clinically
significant arrhythmias, congestive heart failure, transmural
myocardial infarction uncontrolled hypertension (= 180/110),
unstable diabetes mellitus, dyspnea at rest, or chronic therapy
with oxygen
•Concurrent disease or condition that would make the subject
inappropriate for study participation or any serious medical
disorder that would interfere with the subject’s safety
•Unresolved or unstable, serious adverse events from prior
administration of another investigational drug
•Active or uncontrolled infection CTCAE v.4 grade 2 or higher
•Dementia, altered mental status, or any psychiatric condition
that would prevent the understanding or rendering of Informed
Consent
•Treatment with an investigational agent must have stopped at
least 30 days before randomization
•Pregnant or lactating women. Lactation has to stop before
randomization.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method