- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05285332
Classified Treatment Strategy for De-novo Metastatic Breast Cancer After Systemic Adjuvant Therapy (CS)
17. juli 2022 oppdatert av: Yue Yu, Changhai Hospital
Classified Treatment Strategy for De-novo Metastatic Breast Cancer After Systemic Adjuvant Therapywhich Patients Will Benefit From Surgery
For patients with de novo stage IV breast cancer, the current debate is whether local surgery can improve the survival of patients.
There is no clinical study on the classification after systemic treatment of de novo stage IV breast cancer patients.
In fact, the clinical stage of tumor can change with the change of treatment.
For example, the stage Ⅲ of locally advanced breast cancer can down-staging to the stage Ⅱ after systemic treatment.
Similarly, patients with stage Ⅳ can down-staging to stage Ⅱ or stage Ⅲ after systemic treatment.
At this time, the patient can receive surgical treatment.
Therefore, this study is to first treat de novo stage IV breast cancer patients with systemic treatment, according to the response after systemic treatment to give different treatment measures(surgery or continued systemic treatment).
The investigators hope that this study will provide new ideas for the treatment of de novo stage IV breast cancer and other de novo stage IV cancers.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
This study analysed and summarized the outcomes of the primary and metastatic lesions after first-line systemic therapy in patients with newly diagnosed breast cancer and then inferred the timing of surgical treatment.
According to the tumour heterogeneity characteristics between the primary and metastatic tumours, the investigators investigated the following A, B and C scenarios.
After systemic therapy in patients with de novo metastatic breast cancer, the outcomes of primary and metastatic lesions were mainly divided into four categories (Fig. 1a, b, c, d).
It is worth noting that after treatment, the four conditions of a, b, c, and d may alternate with the progression of the tumour or modification of the treatment plan.
Therefore, only a proactive evaluation and timely treatment can identify the time window for tumour treatment.
The time window for surgical treatment is important because, once missed, the tumour may progress with new metastatic lesions.
Figure 1-a: Imaging study indicates complete remission of primary and metastatic tumours.
Diagnostic surgical treatment can be performed to determine whether a pathologic complete response (PCR) is achieved and to develop a subsequent treatment plan.
Figure 1-b: Imaging study indicates complete remission of the metastatic tumour with residual primary tumour.
The state of the patient in this scenario could be equivalent to that of patients with early resectable breast cancer.
Surgical treatment of the primary tumour should be promptly performed.
Figure 1-c: Complete remission of the primary and residual metastatic tumour.
Surgical treatment can be selected for isolated and resectable metastatic tumour.
Figure 1-d: No remission or even progression of the primary and metastatic tumours.
The systemic treatment plan should be replaced, and the surgical treatment should not be considered.
Studietype
Intervensjonell
Registrering (Forventet)
362
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: YU YUE, doctor
- Telefonnummer: +86 13564261349
- E-post: dr-array@hotmail.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Study Population Operable stage IV breast cancer patients, whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imaginology examination
Inclusion Criteria:
- Operable stage IV breast cancer patients,whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imageology examination.
- ECOG-PS 0-2.
- Bone marrow, liver and kidney should be fully functional.
- Patients didn't received the locoregional surgery of the primary tumor in de novo.
- For the patient who accepted systematic treatment before operation, the systematic treatment must be administered within a year since diagnosed.
Exclusion Criteria:
- Accompanied with other primary malignant tumors.
- More than two visceral organ involvement.
- Patients who can't plan for follow-up effectively and regularly.
- Multiple liver metastases with deranged liver function tests (SGOT/SGPT more than four times the upper normal limit).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 1 Primary and metastatic lesions PCR
surgery 1 Mastectomy OR Breast conserving surgery
|
Mastectomy OR Breast conserving surgery
Andre navn:
|
|
Eksperimentell: 2 Primary lesions NPCR and metastatic lesions PCR
surgery 1 Mastectomy OR Breast conserving surgery
|
Mastectomy OR Breast conserving surgery
Andre navn:
|
|
Eksperimentell: 3 Primary lesions PCR and metastatic lesions NPCR
surgery 2 Resection of metastasis
|
Resection of metastasis
Andre navn:
|
|
Eksperimentell: 4 Primary lesions NPCR and metastatic lesions NPCR
Systemic therapy Endocrine therapy or chemotherapy or targeted therapy
|
Endocrine therapy or chemotherapy or targeted therapy
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival
Tidsramme: 5 years
|
Overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.
|
5 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Lokoregional progresjonsfri overlevelse
Tidsramme: 5 år
|
Definert som tiden mellom tidspunktet for diagnosen og tidspunktet for lokoregionalt tilbakefall, eller døden inntraff.
|
5 år
|
|
Fjern progresjonsfri overlevelse
Tidsramme: 5 år
|
Fjern sykdomsfri overlevelse (D-DFS), som defineres som tiden fra diagnosen de novo stadium IV brystkreft til bekreftet tidspunkt for fjern progresjon, eller død på grunn av annen årsak.
|
5 år
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: YU YUE, doctor, Department of thyroid and breast surgery, Changhai Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. august 2022
Primær fullføring (Forventet)
31. desember 2030
Studiet fullført (Forventet)
1. mai 2031
Datoer for studieregistrering
Først innsendt
9. mars 2022
Først innsendt som oppfylte QC-kriteriene
16. mars 2022
Først lagt ut (Faktiske)
17. mars 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. juli 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juli 2022
Sist bekreftet
1. juli 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ChanghaiHTB
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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