Radiothérapie guidée par la génomique dans la prise en charge du cancer du sein triple négatif
Étude de phase II sur la personnalisation de la dose de rayonnement guidée par la génomique dans la prise en charge du cancer du sein triple négatif
The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kamran Ahmed, MD
- Numéro de téléphone: 813-745-3320
- E-mail: Kamran.Ahmed@moffitt.org
Sauvegarde des contacts de l'étude
- Nom: Robin Dowell
- Numéro de téléphone: 813-745-0393
- E-mail: Robin.Dowell@moffitt.org
Lieux d'étude
-
-
Florida
-
Clearwater, Florida, États-Unis, 33756
- Recrutement
- Morton Plant Hospital - Baycare Health System
-
Contact:
- Ken Tardif
- Numéro de téléphone: 727-462-3921
- E-mail: Ken.Tardif@baycare.org
-
Chercheur principal:
- Ronica H. Nanda, MD
-
Tampa, Florida, États-Unis, 33612
- Recrutement
- Moffitt Cancer Center
-
Chercheur principal:
- Kamran Ahmed, MD
-
Chercheur principal:
- Ronica H Nanda, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Participants should have undergone breast conservation therapy with a lumpectomy and axillary evaluation to consist of a sentinel node biopsy or axillary dissection
- Confirmation of Triple Negative (TN) breast cancer by tissue biopsy
- Adequate tissue to calculate RSI
- To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines
- To fulfill the requirement of hormone receptor (HR)- disease, a breast cancer must express (<10%), by immunohistochemistry (IHC), the hormone receptors (estrogen receptor [ER] and progesterone receptor [PR]) as defined in the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) Guidelines
- Life expectancy >16 weeks
- KPS ≥ 70
- Age ≥ 18 years
- Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
- There is no limit on prior systemic therapies
- Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
- Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before study enrollment
Exclusion Criteria:
- Major surgery or significant traumatic injury that has not been recovered from 14 days before study initiation
- Women who are pregnant or breastfeeding
- Positive surgical margins
- History of allergy or hypersensitivity to any of the study drugs or study drug components
- Metastatic breast cancer
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Radiosensitivity Index optimized
Participants will be assigned to optimized arm based on their RSI score. Participants will receive whole breast radiation therapy with or without regional lymph node irradiation as appropriate with or without a boost to the lumpectomy cavity. |
Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with or without a boost of 10 Gy in 5 fractions to the cavity. Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with a boost of 10 Gy in 5 fractions to the cavity. |
|
Comparateur actif: Radiosensitivity Index not optimized
Participants will receive standard of care whole breast radiation therapy with or without regional lymph node irradiation as appropriate with a boost to the lumpectomy cavity. |
Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with or without a boost of 10 Gy in 5 fractions to the cavity. Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with a boost of 10 Gy in 5 fractions to the cavity. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Local Control
Délai: At 3 Years
|
Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging |
At 3 Years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival (OS)
Délai: Up to 5 Years
|
OS will be measured from the date of study initiation to the date of death due to any cause. |
Up to 5 Years
|
|
Progression Free Survival (PFS)
Délai: Up to 5 years
|
PFS is measured from the date of first treatment to the date of first observation of PD or death due to any cause. |
Up to 5 years
|
|
Distant Control
Délai: Up to 5 Years
|
Distant control will be defined by lack of progression outside the irradiated treatment field |
Up to 5 Years
|
|
Quality of Life following Genomically Guided Dose Personalization
Délai: Up to 5 Years
|
Quality of life (QOL) will be assessed through the completion of the Functional Assessment of Cancer Therapy for Breast Cancer questionnaire (FACT-B). This quality of life questionnaire contains questions from the FACT-General (G) questionnaire in the domains of physical, social/family, emotional, and functional well-being as well as additional questions pertaining to patients with breast cancer. The questionnaire will be completed at screening, during protocol therapy and at follow-up visits |
Up to 5 Years
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Kamran Ahmed, MD, Moffitt Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Autres numéros d'identification d'étude
- MCC-21757
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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