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Completed

NCT Number: NCT07601113

PG2 Breast Cancer Evaluation in Adjuvant Medicine-Survival Study

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Chang Gung Memorial Hospital, Kaohsiung Branch, Kaohsiung City, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Astragalus polysaccharides 500 mg

Drug

Adjuvant chemotherapy in combination with PG2

Other names: PG2 Lyo. Injection 500 mg

Placebo

Drug

Adjuvant chemotherapy in combination with Placebo

Primary outcomes

  1. Distant metastasis-free survival

    Time frame: 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 outcomes

  1. Disease-free survival

    Time frame: 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.

  2. Overall Survival

    Time frame: from random assignment to Aug 27, 2025

    Time from random assignment until death from any cause.

Sponsors and collaborators

Lead sponsor

Kun-Ming Rau

Other

Registry information

Official study title

Retrospective Survival Follow-up of Stage II/II Breast Cancer Patients Receiving PG2 Combination With Adjuvant Chemotherapy

Acronym: PG2 BEAM-S

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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