BREAST CANCER TREATMENT REGIMENS

BREAST CANCER TREATMENT REGIMENS
General treatment note: All trastuzumab-containing regimens require cardiac monitoring at baseline and at Months 3, 6, and 9.1
REGIMEN	DOSING
Adjuvant Therapy With Concomitant Trastuzumab
AC (doxorubicin [Adriamycin] +cyclophosphamide [Cytoxan])followed by paclitaxel (Taxol) +concurrent trastuzumab(Herceptin)	Cycles 1–4 Day 1: Doxorubicin 60mg/m2 IV + cyclophosphamide 600mg/m2 IV. Repeat cycle every 3 weeks for 4 cycles. Subsequent cycles Day 1: Paclitaxel 80mg/m2 IV once weekly for 12 weeks, plus Day 1: Trastuzumab 4mg/kg IV loading dose, followed by trastuzumab 2mg/kg IV once weekly (or trastuzumab 6mg/kg IV once every 3 weeks) to complete 1 year of treatment. OR Cycles 1–4 Day 1: Doxorubicin 60mg/m2 IV + cyclophosphamide 600mg/m2 IV. Repeat cycle every 3 weeks for 4 cycles. Subsequent cycles Day 1: Paclitaxel 175mg/m2 IV. Repeat cycle every 3 weeks for 4 cycles, plus Day 1: Trastuzumab 4mg/kg IV loading dose, followed by trastuzumab 2mg/kg IV once weekly (or trastuzumab 6mg/kg IV once every 3 weeks) to complete 1 year of treatment.
Dose-dense AC (doxorubicin +cyclophosphamide) followed bypaclitaxel + concurrent trastuzumab	Cycles 1–4 Day 1: Doxorubicin 60mg/m2 IV + cyclophosphamide 600mg/m2 IV. Repeat cycle every 2 weeks for 4 cycles. Day 2: Pegfilgrastim 6mg SC approximately 24 hrs after chemotherapy. OR Days 3–10: Filgrastim 5mcg/kg (total 300mcg or 480mcg) after chemotherapy. Subsequent cycles Day 1: Paclitaxel 175mg/m2 IV. Repeat cycle every 2 weeks for 4 cycles, plus Day 1: Trastuzumab 4mg/kg IV loading dose, followed by trastuzumab 2mg/kg IV once weekly until completion of paclitaxel. Then administertrastuzumab 6mg/kg IV once every 3 weeks to complete 1 year of treatment. Day 2: Pegfilgrastim 6mg SC approximately 24 hrs after paclitaxel. OR Days 3–10: Filgrastim 5mcg/kg (total 300mcg or 480mcg) after paclitaxel.
Docetaxel (Taxotere) +concurrent trastuzumab	Cycles 1–8 Day 1: Docetaxel 100mg/m2 IV, plus Days 1, 8 and 15: Trastuzumab 2mg/kg. Repeat cycle every 3 weeks for 8 cycles. Subsequent cycles Day 1: Trastuzumab 4mg/kg IV loading dose, followed by trastuzumab 6mg/kg IV once every 3 weeks until disease progression or cumulative toxicity.
Docetaxel + concurrent trastuzumab followed by FEC (5-fluorouracil [5-FU] + epirubicin [Ellence] + cyclophosphamide)	Weeks 1–8 Day 1: Docetaxel 100mg/m2 IV. Repeat cycle every 3 weeks for 3 cycles, plus Day 1: Trastuzumab 4mg/kg IV loading dose, followed by trastuzumab 2mg/kg IV once weekly for 8 weeks. Subsequent cycles Day 1: 5-FU 600mg/m2 IV + epirubicin 60mg/m2 IV + cyclophosphamide 600mg/m2 IV. Repeat cycle every 3 weeks for 3 cycles.
Adjuvant Therapy Without Concomitant Trastuzumab
Exemestane (Aromasin)	Exemestane 25mg orally once daily; used only after 2–3 years of tamoxifen therapy for a total of 5 years hormonal therapy.
Tamoxifen	Tamoxifen 20–40mg orally daily for no longer than 5 years (doses higher than 20mg should be divided into 2 doses, AM and PM).
TAC (docetaxel + doxorubicin +cyclophosphamide)	Day 1: Doxorubicin 50mg/m2 IV, followed by cyclophosphamide 500mg/m2 IV, followed by docetaxel 75mg/m2 IV after a 1-hr interval,plus Days 4–11: Lenograstim 150mcg/m2/day or filgrastim 5mcg/kg/day. Repeat cycle every 3 weeks for 6 cycles.
AC (doxorubicin +cyclophosphamide + paclitaxel)	Cycles 1–4 Day 1: Doxorubicin 60mg/m2 IV + cyclophosphamide 600mg/m2 IV. Repeat cycle every 3 weeks for 4 cycles. Subsequent cycles Day 1: Paclitaxel 80mg/m2 IV once weekly for 12 weeks.
Dose-dense AC (doxorubicin +cyclophosphamide) followed bypaclitaxel	Cycles 1–4 Day 1: Doxorubicin 60mg/m2 IV + cyclophosphamide 600mg/m2 IV. Repeat cycle every 2 weeks. Subsequent cycles Day 1: Paclitaxel 175mg/m2 IV. Repeat cycle every 2 weeks for 4 cycles. All cycles Day 1: Check Hgb levels. Administer darbepoetin alfa 200mcg SC if Hgb <12g/dL for first cycle. Determine Hgb on Day 1 of each subsequent cycle: darbepoetin alfa 200mcg SC if Hgb 10–12g/dL, 300mcg SC if Hgb<10g/dL, withhold if Hgb >12g/dL, plus Day 2: Pegfilgrastim 6mg SC approximately 24 hrs after chemotherapy. OR Days 3–10: Filgrastim 5mcg/kg (total 300mcg or 480mcg) after chemotherapy.
TC (docetaxel +cyclophosphamide)	Day 1: Docetaxel 75mg/m2 IV + cyclophosphamide 600mg/m2 IV. Repeat cycle every 3 weeks for 4 cycles.
Neoadjuvant Therapy
Trastuzumab + paclitaxel + FEC(5-FU + epirubicin +cyclophosphamide)	Cycles 1–4 Day 1: Trastuzumab 4mg/kg IV for one dose (for first dose, administer 1 day before paclitaxel to monitor for infusion reactions), followed by trastuzumab 2mg/kg once weekly for 24 weeks total, plus Day 1: Paclitaxel 225mg/m2 continuous IV infusion over 24 hrs. Repeat cycle every 3 weeks for 4 cycles. Subsequent cycles Day 1: Epirubicin 75mg/m2 IV + cyclophosphamide 500mg/m2 IV, plus Days 1 and 3: 5-FU 500mg/m2 IV. Repeat cycle every 3 weeks for 4 cycles.
Recurrent or Metastatic Breast Cancer—Combination Therapy
Ixabepilone (Ixempra) +capecitabine (Xeloda)	Day 1: Ixabepilone 40mg/m2 IV, plus Days 1–14: Capecitabine 1,000mg/m2 orally twice daily. Repeat cycle every 3 weeks.
FEC (5-FU + epirubicin +cyclophosphamide)	Days 1 and 8: 5-FU 500mg/m2 IV + epirubicin 50mg/m2 IV +cyclophosphamide 400mg/m2 IV. Repeat cycle every 3 or 4 weeks for 6–9 cycles.
EC (epirubicin +cyclophosphamide)	Day 1: Epirubicin 75mg/m2 IV + cyclophosphamide 600mg/m2 IV. Repeat cycle every 3 weeks.
AT (doxorubicin + docetaxel)	Day 1: Doxorubicin 50mg/m2 IV + docetaxel 75mg/m2 IV. Repeat cycle every 3 weeks for max 8 cycles.
Docetaxel + capecitabine	Day 1: Docetaxel 75mg/m2 IV, plus Days 1–14: Capecitabine 1,250mg/m2 (patients ≥60 yrs: reduce to 950mg/m2) orally twice daily. Repeat cycle every 3 weeks.
GT (paclitaxel + gemcitabine [Gemzar])	Day 1: Paclitaxel 175mg/m2 IV, plus Days 1 and 8: Gemcitabine 1,250mg/m2 IV. Repeat cycle every 3 weeks.
Recurrent or Metastatic Breast Cancer—Single-Agent Therapy
Exemestane	Exemestane 25mg orally once daily.
Ixabepilone	Day 1: Ixabepilone 40mg/m2 IV. Repeat cycle every 3 weeks.
Tamoxifen	Tamoxifen 20–40mg orally daily for no longer than 5 years (doses higher than 20mg should be divided into 2 doses, AM and PM).
Pegylated liposomal encapsulated doxorubicin (PLD; Doxil)	Day 1: PLD 50mg/m2 IV. Repeat cycle every 4 weeks.
Albumin-bound paclitaxel(Abraxane)	Day 1: Albumin-bound paclitaxel 260mg/m2 IV. Repeat cycle every 3 weeks.
Capecitabine	Days 1–14: Capecitabine 1,000–1,250mg/m2 orally twice daily. Repeat cycle every 3 weeks.
Recurrent or Metastatic HER2+ Breast Cancer—First-Line Agents with Concomitant Trastuzumab
TPC (trastuzumab + paclitaxel +carboplatin [Paraplatin])	Cycle 1 Day 1: Trastuzumab 4mg/kg IV, followed by Day 2: Paclitaxel 175mg/m2 IV + carboplatin AUC=6mg/mL/min IV,followed by Days 8 and 15: Trastuzumab 2mg/kg IV. Subsequent cycles Days 1, 8 and 15: Trastuzumab 2mg/kg IV, followed by Day 2: Paclitaxel 175mg/m2 IV + carboplatin AUC=6mg/mL/min. Repeat cycle every 3 weeks. After chemotherapy, administer trastuzumab 2mg/kg IV weekly until disease progression or other discontinuation event occurs.
Paclitaxel + trastuzumab	Day 1: Paclitaxel 175mg/m2 IV. Repeat every 3 weeks for 6 cycles, plus Day 1: Trastuzumab 4mg/kg IV loading dose, followed by trastuzumab 2mg/kg IV once weekly until disease progression. OR Day 1: Paclitaxel 80mg/m2 IV once weekly. Repeat cycle every 3 weeks, plus Day 1: Trastuzumab 4mg/kg IV loading dose, followed by trastuzumab 2mg/kg IV once weekly for at least 2 cycles until disease progression.
Docetaxel + trastuzumab	Day 1: Docetaxel 100mg/m2 IV. Repeat cycle every 3 weeks for 6 cycles, plus Day 1: Trastuzumab 4mg/kg IV loading dose, followed by trastuzumab 2mg/kg IV once weekly until disease progression. OR Days 1, 8 and 15: Docetaxel 35mg/m2 IV and trastuzumab 2mg/kg IV (first dose: give trastuzumab 4mg/kg as loading dose). Repeat cycle every 4 weeks until disease progression.
Vinorelbine (Navelbine) +trastuzumab	Day 1: Vinorelbine 2mg/m2 IV once weekly for 8 weeks, plus Day 1: Trastuzumab 4mg/kg IV loading dose, followed by trastuzumab 2mg/kg IV once weekly until disease progression.
Capecitabine + trastuzumab	Days 1–14: Capecitabine 1,250mg/m2 orally twice daily. Repeat cycle every 3 weeks, plus Day 1: Trastuzumab 8mg/kg IV loading dose, followed by trastuzumab 6mg/kg IV once every 3 weeks.
Lapatinib (Tykerb) +trastuzumab for trastuzumab-exposed HER-2 positive disease	Day 1: Lapatinib 1,000mg orally once daily, plus Day 1: Trastuzumab 4mg/kg IV loading dose, followed by trastuzumab 2mg/kg IV once weekly until disease progression.

Source: NCCN Clinical Practice Guidelines in Oncology™. Breast Cancer. v 2.2011.
by
AKSHAYA SRIKANTH
Pharm.D Resident
Hyderabad, India