Background: CLEOPATRA established pertuzumab (P), trastuzumab (T), and docetaxel (D) as the first-line standard of care for pts with HER2-positive MBC. SSTDs were often observed in CLEOPATRA. We report detailed analyses of SSTDs from this phase III study. Methods: The safety population in this analysis included 396 pts in the placebo (Pla) arm (Pla+T+D) and 408 pts in the pertuzumab arm (P+T+D). SSTDs included rash (group term), pruritus, dry skin, alopecia, and nail disorders; incidence, severity (NCI-CTCAE v3.0), management, and outcome were analyzed in both treatment (tx) arms. Results: See table. The most common grade ≥ 3 SSTD in both arms of the study was rash before and after D discontinuation. Median time to onset of SSTDs was 22 days (Pla+T+D) and 20 days (P+T+D). Median duration of SSTDs was 121 days (Pla+T+D) and 96 days (P+T+D). SSTDs required medical tx in 33.8% (Pla+T+D) and 45.9% (P+T+D) of pts. Steroids were frequently used for tx of rash, antibiotics for nail disorders, and antihistamines for pruritus. Repeated episodes of any SSTD occurred in 17% (Pla+T+D) and 26% (P+T+D) of pts. SSTDs led to discontinuation of all study tx in 0.3% (Pla+T+D) and 0.2% (P+T+D) of pts; and discontinuation of D alone in 1.0% (Pla +T+D) and 3.7% (P+T+D) of pts. Conclusions: SSTDs were common in both Pla+T+D and P+T+D arms, although more frequent during D therapy. SSTDs were mostly low-grade, manageable, and rarely resulting in tx discontinuation. There is no specific tx for SSTDs and tx should be empirical, depending on the nature of the SSTD.These results will further inform clinicians on the nature and management of SSTDs for pts who receive P+T+D for the tx of HER2-positive MBC. Clinical trial information: NCT00567190