	US 11,992,529 B2
	Adjuvant treatment of HER2-positive breast cancer
Mark C. Benyunes, San Francisco, CA (US); and Graham Alexander Ross, Hertfordshire (GB)
Assigned to Genentech, Inc., South San Francisco, CA (US); and Hoffmann-La Roche Inc., Little Falls, NJ (US)
Filed by Genentech, Inc., South San Francisco, CA (US); and Hoffmann-La Roche Inc., Little Falls, NJ (US)
Filed on Jul. 9, 2021, as Appl. No. 17/305,556.
Application 17/305,556 is a division of application No. 15/907,718, filed on Feb. 28, 2018, granted, now 11,077,189.
Claims priority of provisional application 62/486,876, filed on Apr. 18, 2017.
Claims priority of provisional application 62/469,317, filed on Mar. 9, 2017.
Claims priority of provisional application 62/466,239, filed on Mar. 2, 2017.
Prior Publication US 2021/0330789 A1, Oct. 28, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 39/395 (2006.01); A61K 9/00 (2006.01); A61K 45/06 (2006.01); A61P 35/00 (2006.01); C07K 16/32 (2006.01); A61K 31/337 (2006.01); A61K 39/00 (2006.01)

CPC A61K 39/39558 (2013.01) [A61K 9/0019 (2013.01); A61K 45/06 (2013.01); A61P 35/00 (2018.01); C07K 16/32 (2013.01); A61K 31/337 (2013.01); A61K 2039/507 (2013.01); A61K 2039/545 (2013.01); A61K 2300/00 (2013.01)]

11 Claims

1. A method of adjuvant therapy for increasing invasive disease free survival (IDFS) at 3 years in patients with HER2-positive, node positive or hormone receptor negative, early breast cancer, comprising administering to said patients, following surgery:

(a) anthracycline-based chemotherapy comprising:

(i) 3 or 4 cycles of 5-fluorouracil+epirubicin+cyclophosphamide (FEC) or 5-fluorouracil+doxorubicin+cyclophosphamide (FAC); or

(ii) 4 cycles of doxorubicin+cyclophosphamide (AC) or epirubicin+cyclophosphamide (EC);

(b) following said anthracycline-based chemotherapy, pertuzumab, trastuzumab, and taxane-based chemotherapy, wherein:

(i) pertuzumab and trastuzumab are each administered intravenously starting on Day 1 of a first taxane-containing cycle and administered for 52 weeks;

(ii) an initial dose of pertuzumab is 840 mg followed every 3 weeks by 420 mg pertuzumab;

(iii) an initial dose of trastuzumab is 8 mg/kg followed every 3 weeks by 6 mg/kg trastuzumab; and

(iv) said taxane-based chemotherapy comprises 3 or 4 cycles of 75 mg/m²and/or 100 mg/m²docetaxel every 3 weeks or 12 cycles of 80 mg/m²paclitaxel every week; and

wherein said IDFS at 3 years from initial administration in said patients is increased compared to patients to whom anthracycline-based chemotherapy, taxane-based chemotherapy, and trastuzumab without pertuzumab are administered.