Capecitabine in the Treatment of Breast Cancer With Low-hormone Receptor Expression After Neoadjuvant Chemotherapy

• Status: Unknown status
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Capecitabine is recommended for adjuvant treatment of advanced or metastatic breast cancer and is particularly effective in patients with triple-negative breast cancer (TNBC).

CREATE-X clinical studies have demonstrated that Capecitabine can further improve prognosis and demonstrate good tolerance in patients who have not achieved pathologic complete response (pCR) after neoadjuvant chemotherapy.

Previous studies have confirmed that the pathological features of the low- hormone receptor (HR)positive population in breast cancer are similar to those in the TNBC population, with a poor prognosis and are not sensitive to adjuvant endocrine therapy.

We hypothesize that the use of Capecitabine in breast cancer patients with residual invasive carcinoma after neoadjuvant chemotherapy may improve prognosis.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Capecitabine; Hormones

Criteria

Inclusion Criteria:

1. Provision of informed consent

2. Women and men at least 18 years of age or older.

3. Pathological confirmation of breast cancer

4. Tumor stage(TNM): T1-4N0-3M0

5. No evidence of distant metastasis

6. Adequate bone marrow, hepatic, and renal function

7. Measurable disease as per RECIST criteria

8. Karnofsky≥70

9. Laboratory criteria:

PLT≥100*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST<2*ULN

Exclusion Criteria:

1. Presence of metastatic disease.

2. Inflammatory breast cancer.

3. Bilateral breast cancer.

4. Postoperative treatment with other adjuvant chemotherapy drugs.

5. Other malignant tumors (concurrent or previous).

6. Pregnant woman.

7. Hypersensitive to any drug in Capecitabine or any ingredient of Capecitabine.

8. Any severe systemic disease contraindicating chemotherapy.