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Trial Title:
Efficacy of Neoadjuvant Endocrine Therapy Compared to Chemotherapy in Breast Cancer Patients
NCT ID:
NCT05755581
Condition:
Female Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Conditions: Keywords:
Neoadjuvant endocrine therapy ,neoadjuvant chemotherapy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients will be randomized into two groups:
The first group (Arm A) will receive NCT; (Any approved Chemotherapy protocol by
guidelines.
The second group(Arm B) will receive NET; GnRH analog Goserelin acetate 3.6 mg every 4
weeks with tamoxifen 20 mg daily for premenopausal patients or an aromatase inhibitor for
postmenopausal patients.
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Hormonal Antineoplastics
Description:
the Neoadjuvant endocrine therapy group will receive neoadjuvant hormonal therapy.
Arm group label:
Neoadjuvant endocrine therapy group
Intervention type:
Drug
Intervention name:
Chemotherapy drug
Description:
the Neoadjuvant chemotherapy group will receive neoadjuvant chemotherapy.
Arm group label:
Neoadjuvant chemotherapy group
Summary:
Eligible patients will be divided into two groups; one will receive neoadjuvant endocrine
therapy and the other one will receive neoadjuvant chemotherapy.
Detailed description:
Patients will be randomized into two groups:
The first group (Arm A) will receive NCT; (Any approved Chemotherapy protocol by
guidelines.
The second group(Arm B) will receive NET; GnRH analog Goserelin acetate 3.6 mg every 4
weeks with tamoxifen 20 mg daily for premenopausal patients or an aromatase inhibitor for
postmenopausal patients.
- Before and during treatments (every 3 weeks for the NCT group, and every 4 weeks for
the NET group), the clinical assessment will be performed for all patients.
- All patients will undergo breast magnetic resonance imaging (MRI) before the start
of treatment, after 12 weeks (3 months) of treatment, and after the end of treatment
before surgery.
- We will determine the objective tumor response with every measurement method and
assess the response according to the Response Evaluation Criteria in Solid Tumor
(RECIST) version 1.1.
- Treatment will be continued for 19-21 weeks before surgery for the chemotherapy
group and 24 weeks for the endocrine therapy group.
- Ki-67 will be assessed using a sample of the core biopsy before treatment and a
surgery specimen after treatment.
- Adverse events will be recorded at every patient visit and will be assessed
according to the Common Terminology Criteria for Adverse Events Version 5.0.
- Surgery will be performed between the 24th and 26th week.
- Arm B Patients who will develop PD or SD after 6 months of treatment will be shifted
to arm A.
The primary endpoint will be;
- The clinical response rate at the end of neoadjuvant treatment, as will be
determined using caliper and MRI measurements.
- A clinical response included either a complete response (CR), a partial response
(PR), Progressive Disease (PD), or Stable Disease (SD) according to the (RECIST)
version 1.1.
Secondary endpoints will be;
- The rate of pathological complete response (pCR).
- The rate of breast conservation surgery.
- Ki-67 changes.
- The length of time to maximum response within a treatment period.
- The Adverse events associated with each treatment arm.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Any histological type of invasive breast cancer. All grades of breast cancer (I, II,
III). ER-positive and/or PR-positive, HER2-negative breast cancer. ER and/or PR
level of positivity ≥34 % (score 4 according to modified Allred score).
Clinical Stages: any T N1-3, or T2-4 any N, M0.
Exclusion Criteria:
- Hormone receptor positivity < 34%. inflammatory breast cancer Metastatic breast
cancer. Recurrent breast cancer. Other malignancy. Unfit patients for chemotherapy.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
amal Ali
Address:
City:
Sohag
Zip:
02
Country:
Egypt
Contact:
Last name:
amal Ali, MD
Phone:
01010454426
Email:
amal_ali@med.sohag.edu.eg
Start date:
April 1, 2023
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Sohag University
Agency class:
Other
Source:
Sohag University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05755581
