Tracking Residual Disease Using Circulating Tumour DNA In High-Risk Early Breast Cancer

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12618001766202
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-26
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion criteria for Pre-screening:
1.Provision of informed consent prior to any study specific procedures (pre-screening PICF)
2.Female or male patients >=18 years of age
3.Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the two following phenotypes:
•Triple negative breast cancer defined as:
Estrogen Receptor (ER) and Progesterone Receptor (PgR) negative defined as immunohistochemistry (IHC) nuclear staining <1%
AND
HER2 negative (not eligible for anti-HER2 therapy) defined as:
–IHC 0, 1+ without ISH OR
–IHC 2+ and ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells OR
–ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells (without IHC)
•ER and/or PgR positive, HER2 negative breast cancer defined as:
ER and/or PgR positive defined as IHC nuclear staining =1%.
AND
HER2 negative (not eligible for anti-HER2 therapy) defined as for TNBC above.
4.Patients have AJCC 8th edition Clinical Prognostic Stage 3 Grade 2 or 3 disease as detailed below:

HistologyGradeTN
Triple negative breast cancerGrade 2-3T3-4 Any N or T2-4N1 or Any T N2-3
Hormone positive (ER+PR+)Grade 2T4 Any N or Any T N3
Grade 3T4 Any N or T3-4N1 or Any T N2-3
Hormone positive (ER+PR-) or (ER-PR+)Grade 2T4 Any N or T3-4N1 or Any T N2-3
Grade 3T3-4 Any N or T2-4 N1 or Any T N2-3

5.Be willing to provide tissue from core biopsy or surgical resection sample for somatic mutation(s) testing. Patients for whom fresh samples cannot be provided may submit an archived specimen.
6.Patients with multifocal or multicentric invasive disease are eligible as long as all the lesions for which HER2 characterization is available are HER2 negative.
7.Patients with synchronous bilateral invasive disease are eligible as long as all the lesions assessed for HER2 on both sides are negative.
•In both the above cases the lesion considered at highest risk for recurrence based on the investigator’s discretion will be used for eligibility determination.
8.ECOG performance status 0-2

INCLUSION CRITERIA FOR MAIN STUDY
1.Provision of informed consent prior to any study specific procedures (main study PICF)
2.Patient has somatic mutation(s) in tissue for assessment of minimal residual disease.
3.Patient has received NAC or AC with curative intent. Please note patient must have received at least one cycle of chemotherapy to be eligible.
4.Patient is willing and able to comply with the protocol procedures for the duration of the study including undergoing blood collection, scheduled visits, examinations and completion of PROs

Exclusion Criteria

EXCLUSION CRITERIA FOR PRE-SCREENING
1.Evidence of metastatic breast cancer
2.HER2 positive disease
3.Grade 1 primary disease
4.Patients with a second primary malignancy. EXCEPTIONS are:
•Adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma.
•Other solid tumours and lymphomas (without bone marrow involvement) diagnosed >= 5 years prior to registration and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was applied.
5.Patients considered at high medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
•Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, extensive bilateral lung disease on High Resolution Computed Tomography scan or any psychiatric disorder that prohibits obtaining informed consent.
6.Patients with known active Hepatitis B or C or HIV
7.Patients who are/will be enrolled in another clinical trial evaluating other drug intervention(s) that will conflict with or interrupt the assessments of this study.
EXCLUSION CRITERIA FOR MAIN STUDY
1.Patient has developed a secondary primary malignancy or metastatic disease since signing the pre-screening consent
2.HER2 positive disease on the surgical specimen.
3.Grade 1 disease on the surgical specimen.

Study & Design

• Study Type: Interventional
• Study Design: Not specified