Capecitabine in the Treatment of Breast Cancer With Low-hormone Receptor Expression After Neoadjuvant Chemotherapy (CALORIE)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Capecitabine
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Capecitabine
Placebo
Arm Description
The experimental group received oral capecitabine for eight cycles.
The placebo group received oral placebo for eight cycles.
Outcomes
Primary Outcome Measures
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.
Overall Survival(OS)
Time from the first dose of Capecitabine or Placebo to death due to any cause.
Secondary Outcome Measures
Full Information
NCT ID
NCT03821454
First Posted
January 26, 2019
Last Updated
January 30, 2019
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03821454
Brief Title
Capecitabine in the Treatment of Breast Cancer With Low-hormone Receptor Expression After Neoadjuvant Chemotherapy
Acronym
CALORIE
Official Title
A Randomized, Double-blind, Placebo-controlled Study of Capecitabine in the Treatment of Early-stage Breast Cancer With Low-hormone Receptor Expression and Residual Invasive Carcinoma After Neoadjuvant Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Anticipated)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
February 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
The investigators will recruit patients who had low- hormone receptor (HR)positive breast cancer of stage I - IIIC and pathologically assessed residual cancer cells (no pathological complete response, non-pCR) after neoadjuvant chemotherapy with anthracycline, taxane, or both. Participants who have residual components of ductal carcinoma in situ are assessed as having a pathological complete response. Participants with tumor-positive lymph nodes excluded.
Other key eligibility criteria are low- hormone receptor (HR)positive, including low-ER and low-PR, low-ER and PR-negative, low-PR and ER-negative. The definition of low hormone receptor (HR) positive is nuclear staining of 1%-10% of the epithelial component of the tumor.
Eligible participants are centrally enrolled after pathological assessment and are randomly assigned in a 1:1 ratio to receive either capecitabine plus standard therapy or standard therapy alone (control).
The trial treatments are standard postsurgical treatments, which included endocrine therapy in participants with estrogen-receptor-positive (nuclear staining ≥ 1%) disease, targeted therapy in participants with HER-2 overexpression and radiotherapy (if indicated), with or without capecitabine.
After surgery, the capecitabine group receive 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. The concomitant administration of postsurgical endocrine therapy is allowed. Postsurgical radiotherapy could be given before or after randomization and could be concomitant with postsurgical endocrine therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine
Arm Type
Experimental
Arm Description
The experimental group received oral capecitabine for eight cycles.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo group received oral placebo for eight cycles.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Oral Placebos (twice per day, on days 1 to 14) every 3 weeks for eight cycles.
Primary Outcome Measure Information:
Title
Event Free Survival(DFS)
Description
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 Frame
Time of Surgery up to 5 years.
Title
Overall Survival(OS)
Description
Time from the first dose of Capecitabine or Placebo to death due to any cause.
Time Frame
First Dose of Capecitabine or Placebo up to 5 years.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ding Xiaowen, DR.
Phone
+86 13588054604
Email
dingxw@zjcc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ding Yuqin
Phone
+86 13588255651
Email
13588255651@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Capecitabine in the Treatment of Breast Cancer With Low-hormone Receptor Expression After Neoadjuvant Chemotherapy
We'll reach out to this number within 24 hrs