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Recruiting Phase 2

Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer

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About this study

HER2-positive and Triple-negative are subtypes of breast cancer more sensitive to systemic therapies, where the complete pathological response rate may be higher than 50%. This gave rise to doubts about the usefulness of traditional local treatments for such responders. Omission of surgery after vacuum assisted breast biopsy (VABB) as well omission of radiotherapy after conservative surgery would now seem to be reasonable alternatives to standard care for highly selected patients, in whom systemic treatments have provided the maximum response.

Condition
Breast Neoplasm Malignant Female
Tested
Omission of local therapies
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Who can join

Age
18 years and older
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 18 years
  • Eligible sex: Female
  • Study condition: Breast Neoplasm Malignant Female
  • Women ≥ 18y.
  • Initial diagnosis of unifocal HER2-positive (regardless of HR status) or Triple-negative (HR positivity lower than 10% is allowed) T1-2, N0-1, M0 breast cancer.
  • Treated with neoadjuvant systemic treatment according to the center recommendations.
  • Maximum responders and/or complete pathological response proved by surgery.
  • Scheduled for breast conservation.
  • Giving specific informed consent.

Exclusion 6

  • One of the inclusion criteria missed.
  • Residual ductal carcinoma in situ (DCIS) at VABB and/or surgery.
  • Bilateral synchronous breast cancer.
  • Previous malignancy within 5 years.
  • BRCA1-2, PALB2 or p53 proven mutation carrier (VUS are exclusion criteria as well).
  • Patients unable to perform regular follow up.

Where

1 site, 1 recruiting

Fondazione IRCCS Istituto Nazionale Tumori Milano

Milan, Italy

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.