Astragalus polysaccharides (APS), acting as an immunomodulator, is known to modulate the tumor microenvironment and inhibit tumor growth and progression, thereby suggesting potential as an adjuvant cancer therapy to improve treatment outcomes. PG2 (APS Injection) has completed a clinical trial (Protocol name: PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance with Chemotherapy among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy , NCT03314805, hereinafter called the parent trial) aimed to show that PG2 treatment among stage II/III breast patients under adjuvant Epirubicin and cyclophosphamide (EC) regimen in reduction of chemotherapy-induced toxicities and encouraging compliance with chemotherapy. This study will further explore whether the addition of PG2 can delay cancer recurrence or metastasis, thereby conferring substantial survival benefits for early breast cancer patients with adjuvant chemotherapy by retrospectively collecting recurrence, metastasis, and survival information from patients enrolled in the parent trial.
Study Type
OBSERVATIONAL
Enrollment
66
Adjuvant chemotherapy in combination with PG2
Adjuvant chemotherapy in combination with Placebo
Chang Gung Memorial Hospital, Kaohsiung Branch
Kaohsiung City, Taiwan
E-Da Cancer Hospital
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital, Lovers Lake branch
Keelung, Taiwan
Chang Gung Memorial Hospital, Taipei Branch
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan City, Taiwan
Distant metastasis-free survival
Time from random assignment to any first event of distant recurrence, death from any cause, or second (non-breast) invasive cancer.
Time frame: from random assignment to Aug 27, 2025
Disease-free survival
Time from random assignment to any first event of invasive ipsilateral or contralateral breast recurrence, local or regional invasive recurrence, distant recurrence, second (non-breast) invasive cancer, or death from any cause.
Time frame: from random assignment to Aug 27, 2025
Overall Survival
Time from random assignment until death from any cause.
Time frame: from random assignment to Aug 27, 2025
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