Survival
Conditions
Keywords
astragalus polysaccharides, breast cancer, adjuvant chemotherapy
Brief summary
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.
Interventions
Adjuvant chemotherapy in combination with PG2
DRUGPlacebo
Adjuvant chemotherapy in combination with Placebo
Sponsors
Kun-Ming Rau
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who were previously enrolled in the \[PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance with Chemotherapy Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy/NCT03314805\] study.
Exclusion criteria
* Non
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distant metastasis-free survival | from random assignment to Aug 27, 2025 | Time from random assignment to any first event of distant recurrence, death from any cause, or second (non-breast) invasive cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | from random assignment to Aug 27, 2025 | 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. |
| Overall Survival | from random assignment to Aug 27, 2025 | Time from random assignment until death from any cause. |
Countries
Taiwan
Contacts
CONTACTKun-Ming Rau
Outcome results
None listed