| Titre |
A Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients With Clinical/Radiologic Complete Response After Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment Without Surgery |
| Protocole ID |
BR005 |
| ClinicalTrials.gov ID |
NCT03188393 |
| Type(s) de cancer |
Sein |
| Phase |
Phase II |
| Type étude |
Autre |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 HOPITAL DU SAINT-SACREMENT
1050 Ch Ste-Foy, Québec, QC, G1S 4L8
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dre Brigitte Poirier
|
| Coordonnateur(trice) |
Fanie Bourgault
418-525-4444 poste 82697
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
- The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients must have had ER analysis performed on the primary breast tumor collected prior to neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testing
- Patients must have had HER2 testing performed on the primary breast tumor collected prior to neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer; patients who have a primary tumor that is HER2-positive, HER2-equivocal, or HER2-negative are eligible
- Patients must have a biopsy marker placed within the tumor bed with imaging confirmation (preferably mammogram but ultrasound or magnetic resonance imaging [MRI] is acceptable) of marker placement prior to neoadjuvant chemotherapy
- Patients with operable focal or multifocal (T1-T3, stage II and IIIA invasive ductal carcinoma [all receptor phenotypes]), and who have completed neoadjuvant chemotherapy with a clinical complete response (by clinical examination)
- Patients must have achieved a complete or near complete radiologic tumor response on breast imaging with mammogram, ultrasound, and MRI
- Patients must be undergoing breast conserving therapy
- Patient must be able to undergo stereotactic-vacuum-assisted breast biopsy with clip placement after completion of neoadjuvant chemotherapy
- Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen
- Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated
- Patients treated with PD-1 or PD-L1 inhibitors, CDK 4/6 inhibitors, or other immune-based therapy are eligible
- Patients with previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible
|
| Critètes d'exclusion |
- T4 tumors including inflammatory breast cancer
- Patients with metastatic disease
- Lumpectomy performed prior to study entry
- Patients with any history of prior radiation therapy in the affected breast
- Patients with synchronous ipsilateral invasive breast cancer or any prior history of ipsilateral invasive breast cancer; (patients with previous ipsilateral/contralateral DCIS or previous contralateral invasive breast cancer treated with anti-cancer therapy are eligible)
- Patients with invasive lobular carcinoma
- Patients who have multicentric disease
- Patients treated with neoadjuvant hormonal therapy only are not eligible
- Patients who are medically unfit to undergo surgical resection
- Patients without breast biopsy marker documented by imaging at tumor bed site prior to initiation of neoadjuvant therapy
- Patients who did not undergo trimodality imaging after completion of neoadjuvant chemotherapy (breast ultrasound, MRI, and mammography)
-
Patients with one or more of the following imaging criteria from any of the 3 imaging modalities after completion of neoadjuvant chemotherapy (NCT) are not eligible:
- Mammogram with malignant appearing calcifications or mass > 1 cm; or
- Ultrasound with a hypoechoic area > 2 cm; or
- Breast MRI demonstrating a residual mass with rapid rise and washout type III kinetics.
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results
- Pregnancy or lactation at the time of study registration; (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to study registration)
|
Groupe d'étude en oncologie du Québec