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Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial for Low Risk DCIS: A Phase III Prospective Randomized Trial.

Research & Trial Information

SCHEMA AFT-25 COMET

Protocol #: AFT-25 COMET

Cancer Type: Breast DCIS

Inclusion Criteria:

  1. New diagnosis of DCIS without invasive cancer; date of diagnosis defined as the date of the first pathology report that diagnosed the patient with DCIS

2. Unilateral, bilateral, unifocal, or multifocal DCIS.

3. ADH/borderline DCIS.

4. A patient who has had a lumpectomy with positive margins as part of their treatment for a current DCIS diagnosis is eligible (post-excision mammogram required at enrollment to establish a new baseline).

5. No previous history of breast cancer (DCIS or invasive cancer) in either breast prior to current DCIS diagnosis.

6. 40 years of age or older at time of DCIS diagnosis.

7. ECOG performance status 0 or 1.

8. No contraindication for surgery.

9.Baseline imaging:

o unilateral DCIS: contralateral normal mammogram ≤ 6 months of registration and ipsilateral breast imaging ≤ 90 days of registration (must include ipsilateral mammogram; can also include ultrasound or breast MRI)

o bilateral DCIS: bilateral breast imaging ≤ 90 days of registration (must include bilateral mammogram; can also include ultrasound or breast MRI)

10. Pathologic criteria: o Any grade I DCIS

o Any grade II DCIS without comedonecrosis

o Absence of invasion or microinvasion

o Diagnosis confirmed on core needle, vacuum-assisted or surgery ≤ 90 days of registration

o ER(+) and/or PR(+) by IHC (≥ 10% staining or Allred score ≥ 4)

o HER2 0, 1+, or 2+ by IHC if HER2 testing is performed

11. Histology slides reviewed and agreement between two clinical pathologists (not required to be at same institution) that pathology fulfils COMET eligibility criteria. In cases of disagreement between the two pathology reviews about whether or not a case fulfils the eligibility criteria, a third pathology review will be required.

12. At least two sites of biopsy for those cases where mammographic extent of calcifications exceeds 4 cm, with second biopsy benign or both sites fulfilling pathology eligibility criteria.

13. Amenable to follow up examinations.

Exclusion Criteria:

1. Male DCIS.

2. Grade II DCIS with comedonecrosis.

3. Papillary or micropapillary DCIS.

4. Concurrent diagnosis of invasive or microinvasive breast cancer in either breast.

5. Documented mass on examination or imaging at site of DCIS prior to biopsy yielding diagnosis of DCIS, with exception of fibroadenoma at a distinct/separate site from site of DCIS. In cases of uncertainty about whether the mass was present on physical examination prior to biopsy, the following criteria should be applied: if mammogram noting abnormal findings is diagnostic MMG = symptomatic/if mammogram noting abnormal findings is screening MMG = asymptomatic.

6. Bloody nipple discharge.

7. Mammographic finding of BIRADS 4 or greater within 6 months of registration at site other than that of known DCIS, without pathologic assessment.

8. Use of investigational cancer agents within 6 weeks prior to diagnosis.

9. Any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent process.

 

 

 

 

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