PG2 Breast Cancer Evaluation in Adjuvant Medicine-Survival Study

NCT07601113 | Not Yet Recruiting

• 1 other identifier: PH-CP026-1
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 5

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.

Conditions

Survival

Keywords

astragalus polysaccharides; breast cancer; adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  from random assignment to Aug 27, 2025

Secondary Outcomes (2)

• Disease-free survival

  from random assignment to Aug 27, 2025

• Overall Survival

  from random assignment to Aug 27, 2025

Study Arms (2)

Treatment

Astragalus polysaccharides 500 mg

Drug: Astragalus polysaccharides 500 mg

Control

Placebo

Drug: Placebo

Interventions

Astragalus polysaccharides 500 mg DRUG

Adjuvant chemotherapy in combination with PG2

Also known as: PG2 Lyo. Injection 500 mg

Treatment

Placebo DRUG

Adjuvant chemotherapy in combination with Placebo

Control

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Non

Sponsors & Collaborators

• Kun-Ming Rau: lead

Study Sites (5)

Chang Gung Memorial Hospital, Kaohsiung Branch

Kaohsiung City, Taiwan

Location

E-Da Cancer Hospital

Kaohsiung City, Taiwan

Location

Chang Gung Memorial Hospital, Lovers Lake branch

Keelung, Taiwan

Location

Chang Gung Memorial Hospital, Taipei Branch

Taipei, Taiwan

Location

Chang Gung Memorial Hospital, Linkou Branch

Taoyuan City, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kun-Ming Rau

CONTACT

ed111215@edah.org.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Superintendent

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5)