Can a faster ovarian suppression drug improve breast cancer treatment?
NCT ID NCT02005887
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This trial tests two drugs, degarelix and triptorelin, in premenopausal women with hormone-sensitive breast cancer. Both drugs temporarily stop the ovaries from making estrogen, which can fuel tumor growth. Women receive one of the drugs along with the hormone therapy letrozole for about six months before surgery. Researchers measure how quickly each drug suppresses estrogen and whether it reduces tumor activity, to see which approach may work better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Two ovarian suppression drugs, degarelix and triptorelin, given alongside the hormone therapy letrozole before breast cancer surgery.
- What this could lead to
- If one drug suppresses ovarian hormones faster and shrinks tumors better, it could point to a more effective pre-surgery treatment for premenopausal women with hormone-sensitive breast cancer.
- What could go wrong
- This is a small phase II trial, so results may not apply broadly. The drugs can cause menopausal symptoms, and the trial does not yet measure long-term outcomes like survival.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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51 people
The number who actually took part.
- Started
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Feb 2014
- Finished
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Aug 2017
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Female gender * Premenopausal status measured within 14 days Prior to randomization: Estradiol (E2) must be above 54 pg/mL (or above 198 pmol/L * Age ≥ 18 years * Performance Status - Eastern Cooperative Oncology Group (ECOG) 0-1 * Histologically confirmed invasive breast cancer: Primary tumor greater than 2 cm Diameter, any nodal stage, no evidence of metastasis (M0) * Primary tumor must have ER and PgR \>50% of the cells * Primary tumor must be HER2-negative (by IHC and/or ISH) * 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), 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. * The patient must be willing to use effective non-hormonal contraception after the pregnancy test and up to surgery. Oral, injectable, or implant hormonal contraceptives or medicated IUD are not allowed within 2 months prior to randomization and during the trial. * 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 for the determination of the primary endpoint. * The patient agrees to make tumor available for submission for central pathology review and for translational studies as part of this protocol Exclusion Criteria: * Postmenopausal * Any hormonal treatment (e.g., oral, injectable, implant, or medicated IUD) in the previous 2 months * Presence of HER2 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 * A history of malignant neoplasms within the past 10 years, except for curatively treated,Basal and squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the bladder * Previous ipsilateral breast cancer (invasive or in situ) at any time * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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A.O "Ospedale di Circolo e Fondazione" Macchi
Varese, 2100, Italy
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Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi di Bologna
Bologna, 40138, Italy
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Istituto Europeo di Oncologia, IEO
Milan, 20141, Italy
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Istituto Toscana Tumori
Prato, 59100, Italy
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Ospedale degli Infermi
Rimini, 47037, Italy
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Ospedali Galliera
Genova, 16128, Italy
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Salvatore Maugeri Fondation
Pavia, 27100, Italy