Effect of Neoadjuvant Chemoradiation on Pathologic Complete Response Rates in Locally Advanced Breast Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-20

Study Completion Date

2024-07-15

Brief Summary

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This is a phase II randomized trial comparing pathologic complete response rates in locally advanced patients recieving either neoadjuvant chemotherapy or neoadjuvant chemoradiation.

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Detailed Description

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A prospective randomized phase II trial, that enrolled locally advanced breast cancer patients who were randomized to recieve either neoadjuvant systemic treatment or neoadjuvant systemic treatment concurrently with radiotherapy. Surgery is done for all patients later on as indicated.

The pathological response rates between both groups will be compared, as well as surgical complications and acute radiation toxicity.

Conditions

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Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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neoadjuvant chemotherapy arm

The patients in this arm will recieve neoadjuvant chemotherapy (with anti-her2 agents if indicated) according to the national guidelines.

post systemic treatment imaging will be done to assess the response, followed by surgery as indicated.

Adjuvant radiotherapy as well as hormonal or target therapy will be prescribed as indicated.

Radiation therapy will be delivered in hypofractionated course (40.05 Gray over 15 fractions with boost to tumor bed 10 Gray over four fractions) to the breast/ chestwall as well as regional lymphatics.

Group Type NO_INTERVENTION

No interventions assigned to this group

Neoadjuvant chemoradiation arm

The patients in this arm will recieve neoadjuvant chemotherapy with preoperative radiotherapy concurrently with taxanes. Surgery is done 6-8 weeks as indicated, followed by systemic treatment according to the guidelines.

Group Type EXPERIMENTAL

neoadjuvant chemoradiation

Intervention Type RADIATION

Neoadjuvant chemoradiation will be prescribed as: 4 cycles of Adriamycin and Cyclophosphamide followed by radiotherapy concurrently with taxanes/ taxanes and carboplatin. followed by surgery as indicated.

Interventions

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neoadjuvant chemoradiation

Neoadjuvant chemoradiation will be prescribed as: 4 cycles of Adriamycin and Cyclophosphamide followed by radiotherapy concurrently with taxanes/ taxanes and carboplatin. followed by surgery as indicated.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. Female patients.
2. Age: 21 years or older.
3. ECOG performance status (PS) score 0 to 2.
4. Locally advanced tumors (stage IIIA or above) of any subtype.
5. Early breast cancer of the HER2+ or TNBC subtype when:

1. Node-negative, T2 or T3.
2. Node-positive, any T stage.

Exclusion Criteria

1. Patients initially presenting with metastatic breast cancer.
2. Patients unfit to receive planned regimen of treatment that had a poor PS (i.e.: PS 3 and 4).
3. Inflammatory breast cancer (T4d) patients.
4. Patients having contraindications to radiotherapy (e.g.: Pregnancy, history of previous chest wall, breast, or axillary irradiation)
5. History of previous ipsilateral breast surgery.
6. Comorbidities that would affect skin healing or integrity, like uncontrolled diabetes mellitus or active autoimmune collagen or vascular diseases

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes