Page 20 - PHESGO (PERTUZUMAB-TRASTUZUMAB) - Product Monograph

Adjuvant chemotherapy regimens
Fixed-dose SC combination of trastuzumab and pertuzumab should start on Day 1

of the first taxane-containing cycle.

Non-anthracycline-based chemotherapy regimen

 6 cycles of docetaxel** + carboplatin ††

Anthracycline-based regimens

 3 or 4 cycles of FEC or FAC , followed by 3 or 4 cycles of docetaxel** or 12 cycles
§§
‡‡
of weekly paclitaxel IIII
 4 cycles of AC or EC***, followed by 3 or 4 cycles of docetaxel** or 12 cycles of
¶¶
weekly paclitaxel IIII

*Docetaxel dosing: 75 mg/m 2 , which could be escalated to 100 mg/m 2 if initial dose was well tolerated (escalation of docetaxel above 75 mg/m 2 is not
recommended when administered with carboplatin as in TRYPHAENA [NCT00976989]).
† FEC dosing in NeoSphere (NCT00545688): 5-fluorouracil (600 mg/m 2 ), epirubicin (90 mg/m 2 ), and cyclophosphamide (600 mg/m 2 ); FEC dosing in
TRYPHAENA and BERENICE (NCT02132949): 5-fluorouracil (500 mg/m ), epirubicin (100 mg/m 2 ), and cyclophosphamide (600 mg/m 2 ).
2
‡ Carboplatin dosing: AUC 6.
§ ddAC dosing: doxorubicin (60 mg/m 2 ) and cyclophosphamide (600 mg/m 2 ) every 2 weeks for 4 cycles with GCSF support.
|| Paclitaxel dosing: 80 mg/m 2 .
¶ AC dosing: 4 cycles of doxorubicin (60 mg/m 2 ) and cyclophosphamide (600 mg/m 2 ) every 3 weeks.
**Docetaxel dosing: 75 mg/m , which could be escalated to 100 mg/m 2 if initial dose was well tolerated (not escalated in non–anthracycline-based
2
regimens); docetaxel dosing following AC or EC administration: 100 mg/m for 3 cycles or 75 mg/m2 for first cycle and 100 mg/m 2 for subsequent 3
2
cycles, or 75 mg/m 2 for 4 cycles.
†† Carboplatin dosing: AUC 6.
‡‡ FEC dosing: 5-fluorouracil (500-600 mg/m 2 ), epirubicin (90-120 mg/m 2 ), and cyclophosphamide (500-600 mg/m 2 ).
§§ FAC dosing: 5-fluorouracil (500-600 mg/m 2 ), doxorubicin (50 mg/m 2 ), and cyclophosphamide (500-600 mg/m 2 ).
IIII Paclitaxel dosing: 80 mg/m 2 .
¶¶ AC dosing: doxorubicin (60 mg/m 2 ) and cyclophosphamide (500-600 mg/m 2 ) every 3 weeks or 2 weeks with GCSF support.
*** EC dosing: epirubicin (90-120 mg/m 2 ) and cyclophosphamide (500-600 mg/m 2 ) every 3 weeks or 2 weeks with GCSF support.

mBC treatment regimen 39,51
Eligible patients with HER2+ mBC should receive fixed-dose SC combination of
trastuzumab and pertuzumab every 3 weeks until disease progression or

unmanageable toxicity, whichever occurs first, alongside at least 6 cycles of
docetaxel.
 In CLEOPATRA (NCT00567190), it was recommended that docetaxel be

administered for a minimum of 6 cycles.
 The docetaxel dose could be decreased by 25% due to toxicity or increased to

100 mg/m in those patients who could tolerate this dose
2
 Fewer than 6 cycles were allowed for unmanageable toxicity
 Comparable docetaxel exposure between the 2 treatment arms in CLEOPATRA
 Docetaxel was administered for a median of 8 cycles in both treatment arms

 Fixed-dose SC combination of trastuzumab and pertuzumab should be
continued until disease progression or unmanageable toxicity.

 If docetaxel is discontinued, fixed-dose SC combination of trastuzumab and
pertuzumab may be continued on its own.

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