Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for HER2 Positive Early Breast Cancer Patients
Neoadjuvant Therapy Study Guided by Drug Screening in Vitro Patient-derived Tumor-like Cell Clusters for HER2 Positive Early Breast Cancer Patients
Neoadjuvant treatment is an important treatment for early breast cancer patients. Patients with her2 enriched subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 positive patients include chemotherapy and targeted therapy. Although the pCR rate was high to 60% after use of trastuzumab and pertuzumab, but the adverse reaction of combined chemotherapy could not be negligible. Some studies have attempted chemotherapy-free treatment for her2 positive patients during neoadjuvant therapy. But, which patient could be exempted from chemotherapy and which drug could be omitted are still unknow before treatment. Drug sensitivity screening in vitro was a promising method for choosing chemotherapy. But there was no method could select effective drugs accurately for breast cancer patients until now.
Previously, investigators developed a patient-derived tumor-like cell clusters in vitro culture technology. Feasibility for guiding clinical treatment by drug sensitivity screening based on this technology have been explored by preliminary exploration with a well corresponding. And the results have been published. This study will explore whether drug screening in vitro patient-derived tumor-like cell clusters from breast cancer tissue could be a metheod for omitting chemotherapy for her2 positive participants.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate. Patients with her2 enriched subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 positive patients include chemotherapy and targeted therapy. Although the pCR rate was high to 60% after use of trastuzumab and pertuzumab, but the adverse reaction of combined chemotherapy could not be negligible. Based on the application of dual targeted drugs, some studies have attempted chemotherapy-free treatment for her2 positive patients during neoadjuvant therapy. But, which patient could be exempted from chemotherapy and which drug could be omitted are still unknow before treatment. Drug sensitivity screening in vitro was a promising method for choosing chemotherapy. But there was no method could select effective drugs accurately for breast cancer participants until now.
Previously, investigators developed a patient-derived tumor-like cell clusters(PTC) in vitro culture technology. It is a cell cluster including tumor cells, mesenchymal cells and lymphocytes, which simulates the tumor microenvironment in vitro. In the preliminary exploration, investigators included 35 early breast cancer participants, the corresponding between in vitro drug sensitivity screening based on this technology and clinical treatment results was well. The results have been published.
This study will focus on her2 positive early breast cancer participants. 46 participants will be included. All of them will received in vitro drug sensitivity screenning upon PTC before neoadjuvant therapy. All participants will received trastuzumab and pertuzumab. The choice of chemotherapy drugs is determined based on the PTC drug sensitivity results. If single-agent chemotherapy is effective in vitro, this drug will be the chemotherapy regimen for the corresponding participants. This study expects that the pCR rate could achieve 60% in the case of chemotherapy downgrading after in vitro drug sensitivity screening.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Chaobin Wang
- Numéro de téléphone: +86 010 88324010
- E-mail: hzwcb1990@163.com
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine, 100044
- Recrutement
- Peking University People's Hospital
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Contact:
- CHAOBIN WANG, Doctor
- Numéro de téléphone: +86 010-88324010
- E-mail: hzwcb1990@163.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- invasive breast cancer
- HER2 positive
- T2 or node positive
- ECOG 0-1
Exclusion Criteria:
- stage IV
- inflammatory breast cancer
- Severe chronic disease
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Neoadjuvant therapy base on PTC drug screenning
Patients will receive neoadjuvant therapy including trastuzumab, pertuzumab, and chemotherapy based on PTC drug screening.
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The choice of chemotherapy is based on the PTC drug sensitivity results.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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pathological complete response(pCR)
Délai: up to 12 weeks
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ypT0/is, ypN0
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up to 12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
survie sans événement (EFS)
Délai: 5 années
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Le temps écoulé entre l'assignation aléatoire et la progression de la maladie, y compris la progression locale avant la chirurgie ; récidive de la maladie - locale, régionale, distante, homolatérale non invasive ou controlatérale (invasive ou non invasive) - ou décès quelle qu'en soit la cause
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5 années
|
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invasive disease-free survival(IDFS)
Délai: 5 years
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The time from surgery to the first documented occurrence of an event defined as ipsilateral invasive local recurrence, ipsilateral locoregional invasive recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause
|
5 years
|
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objective response rate
Délai: up to 12 weeks
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complete response and partial response
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up to 12 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: shu wang, doctor, Peking University People's Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies de la peau
- Tumeurs
- Tumeurs par site
- Maladies du sein
- Tumeurs mammaires
- Mécanismes moléculaires de l'action pharmacologique
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques immunologiques
- Docétaxel
- Carboplatine
- Trastuzumab
- Pertuzumab
Autres numéros d'identification d'étude
- PekingUPH10B003
Informations sur les médicaments et les dispositifs, documents d'étude
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