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The Neoadjuvant Combined Hormone Therapy in Premenopausal Women With Locally Advanced ER+/HER2- Breast Cancer

NCT04753177 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-02-15

No results posted yet for this study

Summary

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.

Conditions

  • The Neoadjuvant Therapy

Interventions

DRUG

Ribocyclib, fulvestrant, triptorelin

Neoadjuvant treatment will last 24 weeks in both groups. A follow-up examination will be carried out every 8 weeks. In the group of combined hormone therapy, repeate cor-biopsy of the tumor is planned to assess the Ki-67

DRUG

Doxorubicin, cyclophosphamide, paclitaxel

Neoadjuvant treatment will last 24 weeks in both groups. A follow-up examination will be carried out every 8 weeks. In the group of combined hormone therapy, repeate cor-biopsy of the tumor is planned to assess the Ki-67

Sponsors & Collaborators

  • Saint Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-28
Primary Completion
2023-01-28
Completion
2024-01-28

Countries

  • Russia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04753177 on ClinicalTrials.gov