PG2 Breast Cancer Evaluation in Adjuvant Medicine-Survival Study (PG2 BEAM-S)
Retrospective Survival Follow-up of Stage II/II Breast Cancer Patients Receiving PG2 Combination With Adjuvant Chemotherapy
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Kaohsiung City, Taiwan
- Chang Gung Memorial Hospital, Kaohsiung Branch
-
Kaohsiung City, Taiwan
- E-Da Cancer Hospital
-
Keelung, Taiwan
- Chang Gung Memorial Hospital, Lovers Lake branch
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Taipei, Taiwan
- Chang Gung Memorial Hospital, Taipei Branch
-
Taoyuan City, Taiwan
- Chang Gung Memorial Hospital, Linkou Branch
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Treatment
Astragalus polysaccharides 500 mg
|
Adjuvant chemotherapy in combination with PG2
Andra namn:
|
|
Control
Placebo
|
Adjuvant chemotherapy in combination with Placebo
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Distant metastasis-free survival
Tidsram: 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.
|
from random assignment to Aug 27, 2025
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Disease-free survival
Tidsram: 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.
|
from random assignment to Aug 27, 2025
|
|
Overall Survival
Tidsram: from random assignment to Aug 27, 2025
|
Time from random assignment until death from any cause.
|
from random assignment to Aug 27, 2025
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PH-CP026-1
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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