Can a faster ovarian suppression drug improve breast cancer treatment?

NCT ID NCT02005887

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

51 people

The number who actually took part.

Started

Feb 2014

Finished

Aug 2017

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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

  • A.O "Ospedale di Circolo e Fondazione" Macchi

    Varese, 2100, Italy

  • Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi di Bologna

    Bologna, 40138, Italy

  • Istituto Europeo di Oncologia, IEO

    Milan, 20141, Italy

  • Istituto Toscana Tumori

    Prato, 59100, Italy

  • Ospedale degli Infermi

    Rimini, 47037, Italy

  • Ospedali Galliera

    Genova, 16128, Italy

  • Salvatore Maugeri Fondation

    Pavia, 27100, Italy