NCT06464913 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Sharma R, Rourke LL, Kronowitz SJ, Oh JL, Lucci A, Litton JK, Robb GL, Babiera GV, Mittendorf EA, Hunt KK, Kuerer HM
Management of local-regional recurrence following immediate breast reconstruction in patients with early breast cancer treated without postmastectomy radiotherapy. Plast Reconstr Surg. 2011 May;127(5):1763-1772. doi: 10.1097/PRS.0b013e31820cf24c.
Shumway DA, Momoh AO, Sabel MS, Jagsi R
Integration of Breast Reconstruction and Postmastectomy Radiotherapy. J Clin Oncol. 2020 Jul 10;38(20):2329-2340. doi: 10.1200/JCO.19.02850. Epub 2020 May 22. No abstract available.

A Randomized Phase II Trial on Omission of Chest Wall Radiotherapy After Implant-Based Breast Reconstruction in Early Breast Cancer Patients

Clinical trial NCT06464913 - References