To assess the safety of giving radiation along with chemotherapy in people with breast cancer who have inadequate response to chemotherapy that was given before surgery.

Phase 2

• Conditions: Health Condition 1: C00-D49- Neoplasms

• Registration Number: CTRI/2020/12/029839
• Lead Sponsor: CHRISTIAN MEDICAL COLLEGE VELLORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Women with age more than 18 years with histologically confirmed diagnosis

of invasive breast cancer of stage I-III invasive mammary carcinoma

irrespective of any hormone receptor status with incomplete pathological

response after neoadjuvant chemotherapy.

2. Receiving radiotherapy to whole breast or chest wall â?? (treatment of regional

nodes permitted) within 6 weeks of surgery date.

3. Completed full course of planned neoadjuvant chemotherapy or at least 4

cycles of neoadjuvant chemotherapy and surgery.

4. Performance score of ECOG 1 or 2.

5. The patient has personally given written, informed consent to participate in

this study, and she fully understands that consent can be withdrawn at any

time without suffering any disadvantages.

6. Not pregnant

7. Willing for contraception during the treatment duration.

8. No clinically significant cardiac disease.

9. No pre-existing skin diseases within the planned radiotherapy field at the

time of study.

10. The patient has maintained sufficient organ function to permit valid

evaluation, with respect to physiology, of the safety of capecitabine and

hormone therapy (LHRH agonists, anti-estrogen agents, and aromatase-

inhibitors), as shown by meeting the following criteria, and she must not

have been administered a blood transfusion and/or hematopoietic factors

within 2 weeks before the tests for these criteria:

a. Leukocyte count: 3,000 to 12,000 /mm3

b. Absolute neutrophil count: >= 1,500 /mm3

c. Platelet count: >= 100,000 /mm3

d. Haemoglobin concentration: >= 9.0g/dL

e. AST (SGOT), ALT (SGPT): <= 2.5 times the upper limit of the medical

institutionâ??s criteria (upper limit of normal)

f. Alkaline phosphatase: <= 2.5 times upper limit of normal

g. Total bilirubin: <= 1.25 times upper limit of normal

h. Serum creatinine: < 1.5 times upper limit of normal

i. Electrocardiography: Normal electrocardiographic parameters

j. Baseline Echocardiogram: Within normal limits. (At least done within

the last 4 months prior to treatment initiation)

Exclusion Criteria

1. Patients not consenting for the study

2. Hypersensitivity to skin film

3. Inflammatory carcinoma of the breast or Pure Ductal Carcinoma in situ

4. Bilateral breast carcinoma -either simultaneous or non-simultaneous

bilateral breast cancer

5. Metastatic breast cancer or History of other malignancies or synchronic

multiple cancers.

6. Considered to require postoperative chemotherapy other than capecitabine.

7. Previously been treated with oral 5-FU agents (however, previous treatment

with IV 5-FU is acceptable).

8. Pregnant, has the potential and/or wishes to become pregnant, or is

breastfeeding.

9. Previously had an organ transplant.

10. Hypersensitivity to fluoropyrimidine agents; has previously suffered severe

adverse drug reactions with fluoropyrimidine agents, regardless of the

presence or absence of dihydropyrimidine dehydrogenase.

11. Currently suffering from serious complications or associated disorders, such

as malignant hypertension, congestive heart failure, coronary failure,

arrhythmias requiring treatment, infectious diseases, and/or haemorrhagic

tendency, and/or has suffered a myocardial infarction within the previous 6

months.

12. On treatment for epilepsy and/or central nervous system disorders.

13. If difficulty in administering orally drugs to the patient, and/or she suffers

from functional insufficiency of the upper gastrointestinal tract

14. For any other reason, the investigator or sub-investigator has judged the

patient to be ineligible for participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified