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Triple Negative Breast CancerPhase 2ESCALATENCT06225284

Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal Triple-negative Early Breast Cancer Patients

A Phase 2 study testing Goserelin Acetate 3.6mg、Goserelin Acetate 10.8mg、Leuprolide Acetate 3.75mg、Leuprorelin Acetate 22.5mg、Triptorelin pamoate 11.25mg、Triptorelin pamoate 22.5mg in people with Triple Negative Breast Cancer and Premenopausal Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Breast cancer (BC), especially premenopausal, is emerging rapidly in East Asia in recent 20 years. Half of the breast cancer patients in Asia are younger than 50 years of age. In general, younger or premenopausal patients are associated with poorer prognosis. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Goserelin Acetate 3.6mg、Goserelin Acetate 10.8mg、Leuprolide Acetate 3.75mg、Leuprorelin Acetate 22.5mg、Triptorelin pamoate 11.25mg、Triptorelin pamoate 22.5mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteTaiwan
Study dates
22 Aug 2024to Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients eligible for inclusion in this study have to fulfill all of the following criteria:
  • Written informed consent must be obtained before any assessment is performed.
  • Female patients aged ≥ 18 years at screening; Must be premenopausal according to serum E2, FSH level.
  • Histological confirmed TNBC, as defined by the most recent ASCO/CAP guidelines. Hormone receptor-low/HER2 negative as defined by ER 1% to <10% and/or PR 1% to <10% on IHC staining; neither hormone receptor may be ≥ 10%; and HER2-negative (IHC 0+/1+, or IHC 2+ plus FISH negative) is allowed.
  • Have previously untreated locally advanced non-metastatic (M0) TNBC and hormone receptor-low/HER2-negative defined as the following combined primary tumor (T) and regional lymph node (N) staging per current AJCC staging criteria for breast cancer staging criteria as assessed by the investigator based on radiological and/or clinical assessment: T1c, N0-N2; or T2, N0-N2; or T3, N0-N2; or T4a-d, N0-N2.
  • Agree to receive core needle biopsy for translational research.
Show all 39Show fewer
  • ECOG 0-1.
  • Patients must have adequate organ and marrow reserve measured within 14 days prior to randomization as defined below:
  • Hemoglobin ≥ 9.0 g/dL;
  • Absolute neutrophil count ≥ 1,500 /μL;
  • Platelets ≥ 100,000/μL;
  • Total bilirubin ≤1.5 x upper normal limit;
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 x upper normal limit;
  • Serum creatinine ≤ 1.5mg/dL or creatinine clearance ≧50ml/min;
  • aPTT < 1.5 x upper normal limit (unless on therapeutic anti-coagulation);
  • Plan to receive breast cancer surgery.
  • Must have a negative pregnancy test obtained within 3 days before starting therapy. Patients must not be breastfeeding.
  • Patients must use effective contraception prior to study entry and for the duration of study participation, and for 6 months after the completion of therapy.
  • Patients (or a surrogate) must be able to comply with study procedures and to give signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the clinical study protocol (CSP). The patients (or a surrogate) must be able to provide of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses.
  • Exclusion criteria Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the Investigator, in order to ensure that the study population will be representative of all eligible patients.
  • Patients have received any prior therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or hormone therapy) for breast cancer.
  • Evidence of systemic metastasis.
  • Pregnancy or lactation.
  • Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs, with exception of hydroxychloroquine (Plaquenil®)) in subjects planning for pembrolizumab use.
  • Has a diagnosis of immunodeficiency or is receiving high dose of systemic steroid therapy. Patients with minor medical disease condition (i.e. mild asthma) requiring prednisolone equal to or less than 20 mg/day or the equivalent may be allowed.
  • Has an active systemic bacterial, viral or fungal infection requiring systemic therapy.
  • Psychiatric illness or social situation that would preclude study compliance.
  • Serious non-healing wound, ulcer, or bone fracture. Except for breast cancer related non-healing wound or ulcer.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrolment.
  • History of allergic reaction to compounds of similar chemical composition to the study drugs.
  • Any of the following conditions or treatments that may impact the safety of the patient:
  • History of, or current, significant cardiac disease including cardiac failure (NYHA functional class II-IV), myocardial infarction (within 6 months), unstable angina (within 6 months), transient ischemic attack (within 6 months), stroke, cardiac arrhythmias requiring treatment or uncontrolled arterial hypertension
  • Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker on screening electrocardiogram (ECG)
  • History of or active severe respiratory disease, including Chronic Obstructive Pulmonary Disease, interstitial lung disease or pulmonary fibrosis
  • Severe hepatic impairment (Child-Pugh class C)
  • Any medically unstable condition as determined by the Investigator
  • Patients unable or unwilling to undergo serial breast tumor biopsy.
  • History of hypersensitivity to any of the study drugs.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chaio Lo, M.D. contact

+886-2-23123456 ext. 265000

chiaolo@ntuh.gov.tw

Yen-Shen Lu, Ph.D. contact

+886-2-23123456 ext. 267513

yslu@ntu.edu.tw

Taiwan1 site, 1 recruiting

  • National Taiwan University Hospital

    Taipei, 100225

    Chiao Lo, M.D., +886223123456 ext. 265000, chiaolo@ntuh.gov.tw

    Yen-Shen Lu, Ph.D., +886223123456 ext. 267513, yslu@ntu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: A Randomized Phase II Study of Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal Triple-negative Early Breast Cancer Patients: ESCALATE Study

Breast cancer (BC), especially premenopausal, is emerging rapidly in East Asia in recent 20 years. Half of the breast cancer patients in Asia are younger than 50 years of age. In general, younger or premenopausal patients are associated with poorer prognosis.

Premenopausal patients have higher estrogen levels than those in older (postmenopausal) patients. Estrogen is known to suppress anti-tumor T cell response and leading to tumor progression in different animal models (Clin Cancer Res 2016 22:6204), including lung cancer, melanoma, ovarian cancer. One of the mechanisms that contributes to estrogen's suppression of T cell function is via the mobilization of myeloid-derived suppressor cells (MDSC). Targeting ER signaling with hormonal therapy can abolish MDSC mobilization, and sensitize tumor cells to antigen specific T cell or NK cell killing (Cancer Discovery 2018 7:72 2017). These study results further support the hypothesis that, E2 is associated with immunosuppressive effect, and may contribute to the suppression of immune surveillance in young female breast cancer patients. These results suggest that E2 may suppress anti-tumor immunity, and E2 reduction improve the anti-tumor immunity. In our preliminary works, the investigators found higher dose (equivalent to premenopausal women serum level) of E2 suppressed T cell activities, while lower dose E2 (postmenopausal serum level) activated T cell activity. The investigators have investigated the combination of anti-PD1 antibody and GnRH agonist plus exemestane (an aromatase inhibitor which will block the production of E2 from adipose tissue) in ER positive premenopausal breast cancer patient refractory to prior endocrine therapy in metastatic setting. The response rate was 38.4%, and median progression-free survival (PFS) was 10.2 months. This outstanding result were presented in AACR 2021 oral session (Cancer Res 2021 81:13_Supplement, CT028). On the other hand, progesterone is also well known for its anti-inflammation and immune tolerance activity. This possibly makes estrogen reduction treatments, such as gonadotropin-releasing hormone agonist (GnRH agonist), an important partner in augmenting neoadjuvant therapy for patients with premenopausal breast cancer.

Read more

For triple negative breast cancer (TNBC), endocrine therapy has no anti-tumor effect. On the other hand, the use of GnRH agonist has been tested for the protection of ovary function of young female while receiving adjuvant chemotherapy. Surprisingly, the concomitant use of goserelin and adjuvant chemotherapy improved disease-free survival (HR 0.47, P=0.04) and overall survival (HR 0.45, P=0.05) versus chemotherapy alone in ER negative premenopausal early BC patients in POEMS study, which was initially aimed to improve the success pregnant rate (N Engl J Med 2015 372;923). Endocrine therapy is theoretically antagonist to chemotherapy therapy when concomitantly use. In another report analyzed the outcome of both pre- and postmenopausal women who entered two randomized trials (Gruppo Oncologico Nord-Ovest-Mammella Intergruppo studies) on adjuvant chemotherapy and received either concomitant or sequential hormonal therapy. The result showed a decreasing trend (P = 0.015) in hazard ratio of death with increasing age was observed, indicating that concomitant therapy is more effective than sequential therapy in young patients (Annals of Oncology 2008;19(2):299-307). These results support the hypothesis that, E2 suppression/ER inhibition therapy may modulate immune microenvironment, thereby enhancing the chemotherapy induced immunogenic death effect.

The investigators hypothesized that, estrogen level reduction by ovarian function suppression can modulate immune microenvironment, thereby augmenting adjuvant chemotherapy efficacy, regardless of the estrogen receptor (ER) status of cancer cell. Therefore, the investigators plan to test this hypothesis in real clinical model, with standard clinical recommended treatment doses.

The study is designed to evaluate whether the GnRH agonist can provide the therapeutic benefit for premenopausal TNBC patients via modulating immune microenvironment. Premenopausal TNBC patients will receive GnRH agonist and neoadjuvant chemotherapy, and the efficacy and immune microenvironment change of co-administration arm will be measured and compared with chemotherapy alone control arm.

Being tested
Goserelin Acetate 3.6mg、Goserelin Acetate 10.8mg、Leuprolide Acetate 3.75mg、Leuprorelin Acetate 22.5mg、Triptorelin pamoate 11.25mg、Triptorelin pamoate 22.5mg
Keywords
Neoadjuvant chemotherapy, Triple negative breast cancer, Gonadotropin Releasing Hormone Agonist, Premenopausal Breast Cancer
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Goserelin Acetate 3.6mg、Goserelin Acetate 10.8mg、Leuprolide Acetate 3.75mg、Leuprorelin Acetate 22.5mg、Triptorelin pamoate 11.25mg、Triptorelin pamoate 22.5mgDrug

    After randomization, patients in the experimental arm (Arm A) will receive GnRH agonist injection within 7 days of randomization and during neoadjuvant chemotherapy treatment. The choice of GnRH agonist, including goserelin, leuprorelin and triptorelin giving in monthly, three-monthly or sixth-monthly, will be made by per investigator's discretion.

Study groups in NCT06225284
Study groupRoleWhat they receive
Arm AExperimentalAfter randomization, patients in the experimental arm (Arm A) will receive GnRH agonist injection within 7 days of randomization and during neoadjuvant chemotherapy treatment. The protocol-defined chemotherapy will be given 7 to 14 days after GnRH agonist injection. The choice of GnRH agonist, including goserelin, leuprorelin and triptorelin giving in monthly, three-monthly or sixth-monthly, will be made by per investigator's discretion. * Anthracycline-cyclophosphamide combination or Anthracycline-cyclophosphamide combination, dose-dense schedule * Taxane (docetaxel or paclitaxel) ± optional platinum (Use of platinum or not will be stratified.) * Optional pembrolizumab(Use of pembrolizumab or not will be stratified.)
Receives: Drug: Goserelin Acetate 3.6mg、Goserelin Acetate 10.8mg、Leuprolide Acetate 3.75mg、Leuprorelin Acetate 22.5mg、Triptorelin pamoate 11.25mg、Triptorelin pamoate 22.5mg
Arm BNo intervention* Anthracycline-cyclophosphamide combination or Anthracycline-cyclophosphamide combination, dose-dense schedule * Taxane (docetaxel or paclitaxel) ± optional platinum (Use of platinum or not will be stratified.) * Optional pembrolizumab(Use of pembrolizumab or not will be stratified.)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response rate

    No invasive residual in breast or nodes; non-invasive breast residuals allowed

    Measured: During surgery

Secondary outcomes (11)

  1. Event free survival

    To compare the event-free survival (EFS) assessed by investigator in ITT population after neoadjuvant chemotherapy with/without ovary suppression

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

  2. Quality of life from patient-report outcome

    Quality of life will be assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 , the minimum values is : 30 , the maximum values is : 126, the higher scores mean a worse outcome

    Measured: At Screening phase, at Treatment 1 cycle 4 day 1 ( each cycle is 14 days or 21 days) , at Treatment 2 cycle 4 day 1 (each cycle is 14 days or 21 days), through study completion, an average of 5 years

  3. Estradiol

    Estradiol (E2) pg/mL

    Measured: At Screening phase, at Treatment 1 cycle 1 day 1, at Treatment 1 cycle 3 day 1, at Treatment 2 cycle 1 day 1, at Treatment 2 cycle 3 day 1, during surgery, through study completion, an average of 5 years

  4. Follicle stimulating hormone

    Follicle stimulating hormone (FSH) mIU/mL

    Measured: At Screening phase, at Treatment 1 cycle 1 day 1, at Treatment 1 cycle 3 day 1, at Treatment 2 cycle 1 day 1, at Treatment 2 cycle 3 day 1, during surgery, through study completion, an average of 5 years

  5. Luteinizing hormone

    Luteinizing hormone (LH) mIU/mL

    Measured: At Screening phase, at Treatment 1 cycle 1 day 1, at Treatment 1 cycle 3 day 1, at Treatment 2 cycle 1 day 1, at Treatment 2 cycle 3 day 1, during surgery, through study completion, an average of 5 years

  6. Tumor microenvironment changes after neoadjuvant chemotherapy with/without ovarian suppression

    To evaluate the tumor-infiltrating lymphocytes (TIL)

    Measured: At Screening phase, at Treatment 1 cycle 1 day 1 ( each cycle is 14 days or 21 days), at Treatment 2 cycle 1 day 1 ( each cycle is 14 days or 21 days), through study completion, an average of 5 years

  7. Pathological complete response by tumor infiltrating lymphocyte

    To evaluate the rate of pCR (ypT0/Tis ypN0) as assessed by the local pathologist at the time of definitive surgery in individuals with TIL(+) or TIL(-) tumors.

    Measured: During surgery

  8. Residual cancer burden

    To evaluate Residual Cancer Burden (RCB) as assessed by the local pathologist at the time of definitive surgery

    Measured: During surgery

  9. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    To determine the safety and tolerability of ovarian function suppression in combination with neoadjuvant chemotherapy in locally advanced TNBC subjects

    Measured: up to 32 weeks

  10. Breast cancer quality of life from patient-report outcome

    Breast cancer quality of life will be assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire BR23 , the minimum values is : 22 , the maximum values is : 92, the higher scores mean a worse outcome

    Measured: At Screening phase, at Treatment 1 cycle 4 day 1 ( each cycle is 14 days or 21 days) , at Treatment 2 cycle 4 day 1 ( each cycle is 14 days or 21 days), through study completion, an average of 5 years

  11. Event free survival by tumor infiltrating lymphocyte

    To evaluate the event free survival by investigator in individuals with TIL(+) or TIL(-) tumors.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2024
  2. Study start22 Aug 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06225284
Sponsor's protocol ID
202309050MIPB
Acronym
ESCALATE
Status last verified
Apr 2025
First submitted
10 Dec 2023
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lin CH, Yap YS, Lee KH, Im SA, Naito Y, Yeo W, Ueno T, Kwong A, Li H, Huang SM, Leung R, Han W, Tan B, Hu FC, Huang CS, Cheng AL, Lu YS; Asian Breast Cancer Cooperative Group. Contrasting Epidemiology and Clinicopathology of Female Breast Cancer in Asians vs the US Population. J Natl Cancer Inst. 2019 Dec 1;111(12):1298-1306. doi: 10.1093/jnci/djz090.

    PubMed 31093668

  • Fan L, Strasser-Weippl K, Li JJ, St Louis J, Finkelstein DM, Yu KD, Chen WQ, Shao ZM, Goss PE. Breast cancer in China. Lancet Oncol. 2014 Jun;15(7):e279-89. doi: 10.1016/S1470-2045(13)70567-9.

    PubMed 24872111

  • Bauer KR, Brown M, Cress RD, Parise CA, Caggiano V. Descriptive analysis of estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative invasive breast cancer, the so-called triple-negative phenotype: a population-based study from the California cancer Registry. Cancer. 2007 May 1;109(9):1721-8. doi: 10.1002/cncr.22618.

    PubMed 17387718

  • Dent R, Trudeau M, Pritchard KI, Hanna WM, Kahn HK, Sawka CA, Lickley LA, Rawlinson E, Sun P, Narod SA. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4429-34. doi: 10.1158/1078-0432.CCR-06-3045.

    PubMed 17671126

  • Park YH, Senkus-Konefka E, Im SA, Pentheroudakis G, Saji S, Gupta S, Iwata H, Mastura MY, Dent R, Lu YS, Yin Y, Smruti BK, Toyama T, Malwinder S, Lee SC, Tseng LM, Kim JH, Kim TY, Suh KJ, Cardoso F, Yoshino T, Douillard JY. Pan-Asian adapted ESMO Clinical Practice Guidelines for the management of patients with early breast cancer: a KSMO-ESMO initiative endorsed by CSCO, ISMPO, JSMO, MOS, SSO and TOS. Ann Oncol. 2020 Apr;31(4):451-469. doi: 10.1016/j.annonc.2020.01.008. Epub 2020 Jan 16.

    PubMed 32081575

  • Liedtke C, Mazouni C, Hess KR, Andre F, Tordai A, Mejia JA, Symmans WF, Gonzalez-Angulo AM, Hennessy B, Green M, Cristofanilli M, Hortobagyi GN, Pusztai L. Response to neoadjuvant therapy and long-term survival in patients with triple-negative breast cancer. J Clin Oncol. 2008 Mar 10;26(8):1275-81. doi: 10.1200/JCO.2007.14.4147. Epub 2008 Feb 4.

    PubMed 18250347

  • Carey LA, Dees EC, Sawyer L, Gatti L, Moore DT, Collichio F, Ollila DW, Sartor CI, Graham ML, Perou CM. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res. 2007 Apr 15;13(8):2329-34. doi: 10.1158/1078-0432.CCR-06-1109.

    PubMed 17438091

  • Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Swain SM, Prowell T, Loibl S, Wickerham DL, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas EP, Bergh J, Semiglazov V, Justice R, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching PA, Slaets L, Tang S, Gerber B, Geyer CE Jr, Pazdur R, Ditsch N, Rastogi P, Eiermann W, von Minckwitz G. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014 Jul 12;384(9938):164-72. doi: 10.1016/S0140-6736(13)62422-8. Epub 2014 Feb 14.

    PubMed 24529560

  • von Minckwitz G, Untch M, Nuesch E, Loibl S, Kaufmann M, Kummel S, Fasching PA, Eiermann W, Blohmer JU, Costa SD, Mehta K, Hilfrich J, Jackisch C, Gerber B, du Bois A, Huober J, Hanusch C, Konecny G, Fett W, Stickeler E, Harbeck N, Muller V, Juni P. Impact of treatment characteristics on response of different breast cancer phenotypes: pooled analysis of the German neo-adjuvant chemotherapy trials. Breast Cancer Res Treat. 2011 Jan;125(1):145-56. doi: 10.1007/s10549-010-1228-x. Epub 2010 Nov 3.

    PubMed 21042932

  • Schmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.

    PubMed 32101663

  • Schmid P, Cortes J, Dent R, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Untch M, Fasching PA, Cardoso F, Andersen J, Patt D, Danso M, Ferreira M, Mouret-Reynier MA, Im SA, Ahn JH, Gion M, Baron-Hay S, Boileau JF, Ding Y, Tryfonidis K, Aktan G, Karantza V, O'Shaughnessy J; KEYNOTE-522 Investigators. Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer. N Engl J Med. 2022 Feb 10;386(6):556-567. doi: 10.1056/NEJMoa2112651.

    PubMed 35139274

  • Finn OJ. Cancer immunology. N Engl J Med. 2008 Jun 19;358(25):2704-15. doi: 10.1056/NEJMra072739. No abstract available.

    PubMed 18565863

  • Yarchoan M, Johnson BA 3rd, Lutz ER, Laheru DA, Jaffee EM. Targeting neoantigens to augment antitumour immunity. Nat Rev Cancer. 2017 Apr;17(4):209-222. doi: 10.1038/nrc.2016.154. Epub 2017 Feb 24.

    PubMed 28233802

  • Smith CC, Selitsky SR, Chai S, Armistead PM, Vincent BG, Serody JS. Alternative tumour-specific antigens. Nat Rev Cancer. 2019 Aug;19(8):465-478. doi: 10.1038/s41568-019-0162-4. Epub 2019 Jul 5.

    PubMed 31278396

  • Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012 Mar 22;12(4):252-64. doi: 10.1038/nrc3239.

    PubMed 22437870

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Goserelin Acetate 3.6mg、Goserelin Acetate 10.8mg、Leuprolide Acetate 3.75mg、Leuprorelin Acetate 22.5mg、Triptorelin pamoate 11.25mg、Triptorelin pamoate 22.5mg in people with Triple Negative Breast Cancer and Premenopausal Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chaio Lo, M.D. (+886-2-23123456 ext. 265000, chiaolo@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (time frame: During surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06225284, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.

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