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NCT04753177
The Neoadjuvant Combined Hormone Therapy in Premenopausal Women With Locally Advanced ER+/HER2- Breast Cancer
Phase 2, PHASE3 trial testing Ribocyclib, fulvestrant, triptorelin in The Neoadjuvant Therapy in 120 participants. Status unknown.
28 January 2023
Quick facts
| Lead sponsor | Saint Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 28 January 2021 |
| Primary completion | 28 January 2023 |
| Estimated completion | 28 January 2024 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Ribocyclib, fulvestrant, triptorelin — full drug profile →
- Doxorubicin, cyclophosphamide, paclitaxel — full drug profile →
Conditions studied
- The Neoadjuvant Therapy — all drugs for The Neoadjuvant Therapy →
Sponsor
Saint Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary
Who can join
Adults 18 to 60, female only, with The Neoadjuvant Therapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Breast cancer take a leading position in the structure of morbidity and mortality from malignant tumors among women. Today the interest of many scientists and pharmaceutical companies is focused on the study of metastatic breast cancer forms. While we obtain little experimental data and practical research about the treatment of locally advanced forms. In this regard, the study of new neoadjuvant drug therapy regimen for estrogen-receptor positive breast cancer in premenopausal woman is very relevant. The proposed research will be the absolutely innovative investigation worldwide. The study will consist of two modes of treatment, combined hormone therapy with CDK4/6-ingibitors and chemotherapy (the control), each replicated four times in a randomized, complete block design. This research aims to improve the results of treatment, namely to increase the percentage of successfully treated patients and reduce toxicity from treatment. Primary study endpoints will include the frequency of objective response and complete pathomorphological response (according to the Miller-Payne classification). Secondary endpoints will include a decrease of the Ki67 level in postoperative material compared to primary biopsy, the frequency of organ-preserving operation after neoadjuvant treatment and quality of life. Study hypothesis: neoadjuvant combined hormone therapy with CDK4/6-ingibitors in premenopausal women with luminal breast cancer leads to at least the same results as neoadjuvant chemotherapy, but with less toxicity.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04753177 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Saint Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary
- Last refreshed: 15 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04753177.
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