Breast Cancer Clinical Trial
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
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.
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.
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