Efficacy of Neoadjuvant Endocrine Therapy Compared to Chemotherapy in Breast Cancer Patients
Study Details
Study Description
Brief Summary
Eligible patients will be divided into two groups; one will receive neoadjuvant endocrine therapy and the other one will receive neoadjuvant chemotherapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
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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.
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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.
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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.
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Treatment will be continued for 19-21 weeks before surgery for the chemotherapy group and 24 weeks for the endocrine therapy group.
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Ki-67 will be assessed using a sample of the core biopsy before treatment and a surgery specimen after treatment.
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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.
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Surgery will be performed between the 24th and 26th week.
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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;
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The clinical response rate at the end of neoadjuvant treatment, as will be determined using caliper and MRI measurements.
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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;
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The rate of pathological complete response (pCR).
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The rate of breast conservation surgery.
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Ki-67 changes.
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The length of time to maximum response within a treatment period.
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The Adverse events associated with each treatment arm.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Neoadjuvant chemotherapy group Patients in this arm will receive neoadjuvant chemotherapy as usual |
Drug: Chemotherapy drug
the Neoadjuvant chemotherapy group will receive neoadjuvant chemotherapy.
|
| Active Comparator: Neoadjuvant endocrine therapy group Patients in this group will receive neoadjuvant endocrine therapy |
Drug: Hormonal Antineoplastics
the Neoadjuvant endocrine therapy group will receive neoadjuvant hormonal therapy.
|
Outcome Measures
Primary Outcome Measures
- Clinical response rate [6 months]
The primary endpoint will be; The clinical response rate at the end of neoadjuvant treatment, as will be determined using caliper and MRI measurements according to the (RECIST) version 1.1.
Secondary Outcome Measures
- pathological complete response [6 months]
The rate of pathological complete response after surgery.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | amal Ali | Sohag | Egypt | 02 |
Sponsors and Collaborators
- Sohag University
Investigators
- Principal Investigator: Amal Ali, MD, Assistant lecturer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Soh-Med-23-02-16