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

NCT03821454 | Unknown

• 1 other identifier: CALORIE
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Event Free Survival(DFS)

  First Dose of Capecitabine or Placebo to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse.

  Time of Surgery up to 5 years.

• Overall Survival(OS)

  Time from the first dose of Capecitabine or Placebo to death due to any cause.

  First Dose of Capecitabine or Placebo up to 5 years.

Study Arms (2)

Capecitabine

EXPERIMENTAL

The experimental group received oral capecitabine for eight cycles.

Drug: Capecitabine

Placebo

PLACEBO COMPARATOR

The placebo group received oral placebo for eight cycles.

Drug: Placebos

Interventions

Capecitabine DRUG

Oral capecitabine (at a dose of 1250 mg per square meter of body-surface area, twice per day, on days 1 to 14) every 3 weeks for eight cycles.

Capecitabine

Placebos DRUG

Oral Placebos (twice per day, on days 1 to 14) every 3 weeks for eight cycles.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent
• Women and men at least 18 years of age or older.
• Pathological confirmation of breast cancer
• Tumor stage(TNM): T1-4N0-3M0
• No evidence of distant metastasis
• Adequate bone marrow, hepatic, and renal function
• Measurable disease as per RECIST criteria
• Karnofsky≥70
• Laboratory criteria:
• PLT≥100\*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST\<2\*ULN

You may not qualify if:

• Presence of metastatic disease.
• Inflammatory breast cancer.
• Bilateral breast cancer.
• Postoperative treatment with other adjuvant chemotherapy drugs.
• Other malignant tumors (concurrent or previous).
• Pregnant woman.
• Hypersensitive to any drug in Capecitabine or any ingredient of Capecitabine.
• Any severe systemic disease contraindicating chemotherapy.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Ding Xiaowen, DR.

CONTACT

+86 13588054604; dingxw@zjcc.org.cn

Ding Yuqin

CONTACT

+86 13588255651; 13588255651@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2019
• First Posted: January 29, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share