Angiomammography and Neoadjuvant Chemotherapy

Breast Neoplasms Clinical Trial

Official title:

Usefulness of Angiomammography for Predicting the Response to Neoadjuvant Chemotherapy in Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05402930
• Other study ID #: 2019-4433
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The best prognostic factor following neoadjuvant chemotherapy is the pathological complete response (pCR). pCR is defined as the absence of invading cells in the breast and lymph nodes following neoadjuvant chemotherapy treatment. Since patients with pCR have a better prognosis than those without pCR, some studies have evaluated different methods to predict pCR early in treatment. Thus, patients who do not respond optimally to treatment could be identified early and changed treatment in order to maximize the chances of pCR and avoid the morbidity of poorly effective treatments. To do this, several modalities have been proposed, including MRI, mammography, ultrasound, positron emission tomography, elastography, and serial biopsies, but these techniques have shown predictive and sometimes expensive. Nevertheless, assessment of tumor response after cycle 2 has been suggested to be appropriate for the prediction of pCR. The main objective of this study is to compare the performance of two diagnostic modalities, namely CESM and MRI, in the evaluation of the response of a malignant breast tumor to neoadjuvant chemotherapy and the prediction of pCR. The radiological response will also be compared to the clinical response.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female aged 18 and over
• Histologically proven breast cancer by large gauge needle
• No evidence of distant metastasis
• Neoadjuvant chemotherapy with or without concomitant targeted therapy
• Breast tumor initially measurable by clinical examination

Exclusion Criteria:

• Refusal to perform the biopsy or surgery
• Pregnant or possibly pregnant woman
• Usual contraindication to contrast product
• Significant kidney failure
• Allergy to contrast medium
• frank hyperthyroidism
• Usual contraindications to MRI

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Diagnostic Test:
• Angiomammography
Patients will receive their care in a standard manner. Breast MRI is one modality used by physicians to monitor response to neoadjuvant chemotherapy and will therefore be used as standard. A CESM exam will be added at the same time as the MRI. Patients will have a physical exam, breast MRI and CESM before the start of chemotherapy (less than 2 weeks). These examinations will be repeated after cycle 2 (±1 week) and at the end of chemotherapy. After each cycle of chemotherapy, the tumor will be measured in two axes by the attending physician. Histological examination of the surgical specimen will be used to determine the pCR. Responses observed on MRI and CESM will be compared to pCR.

Locations

Country	Name	City	State
Canada	St-Sacrement Hospital	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with a pCR accoreding to angiomammography, based on a 50% reduction in lesion size at angiomammography	Prediction of pCR using angiomammography after cycle 2 of neoadjuvant chemotherapy, based on a 50% reduction in lesion size at angiomammography	Cycle 2 (each cycle being 21 days), i.e., after the chemotherapy on day 1 of cycle 2 and before cycle 3.