regimen-monograph

CRBPDOCETRAS

Intent

Palliative

Regimen Category

Local

Drugs Used

DOCEtaxel , CARBOplatin , trastuzumab

A - Regimen Name

CRBPDOCETRAS Regimen

CARBOplatin-DOCEtaxel-Trastuzumab (DCH)

Disease Site

Breast

Intent

Palliative

Regimen Category

Local : A regimen not widely used by Regional Cancer Centres in this disease site.

Rationale and Uses

Chemotherapy treatment for patients with HER2 positive metastatic breast cancer

B - Drug Regimen

Q3 Weekly Chemotherapy:

DOCEtaxel

(Round to nearest 1 mg)

75 mg /m²

Day 1

CARBOplatin

(Round to nearest 10 mg)

AUC 6

Day 1

(Continued on next page)

PLUS

Weekly Trastuzumab Dosing

trastuzumab

(Round to nearest 1 mg)

4 mg /kg

IV over 90 minutes

Day 1 - Loading dose (first cycle only)

then

trastuzumab

(Round to nearest 1 mg)

2 mg /kg

IV over 30 minutes (if loading dose is well-tolerated)

Day 8, 15 (first cycle only); Days 1, 8, 15 (starting 2nd cycle)

Q3 Weekly Trastuzumab Dosing

trastuzumab

(Round to nearest 1 mg)

8 mg /kg

IV over 90 minutes

Day 1 (Loading dose - first cycle only)

then

trastuzumab

(Round to nearest 1 mg)

6 mg /kg

IV over 30 minutes (if loading dose is well-tolerated)

Day 1 (starting second cycle)

_{¹Adjust Carboplatin dose to AUC target (using Calvert formula) or in response to platelet counts (using Egorin formula - if previously treated with thrombocytopenic agent), as outlined in "Other Notes" section.}
_{²If delay more than 1 week, the loading dose should be repeated.}

C - Cycle Frequency

REPEAT EVERY 21 DAYS

• Docetaxel and Carboplatin: For a maximum of 6-8 cycles, unless metastatic progression or unacceptable toxicity

• Trastuzumab: Continue until disease progression or unacceptable toxicity. Refer to TRAS Advanced breast regimen for details

D - Premedication and Supportive Measures

Antiemetic Regimen:

Moderate (with Docetaxel and Carboplatin)

Other Supportive Care:

Dexamethasone 8 mg po bid for 3 days starting 1 day prior to docetaxel (prevent anaphylaxis / fluid retention.)

Trastuzumab: To prevent recurrence of infusion-associated reactions, acetaminophen and diphenhydramine may be given as pre-medication. Refer to Trastuzumab drug monograph for full details.

E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and could be considered.

In general, the dose of trastuzumab should be delayed if the chemotherapy cycle is delayed for scheduling convenience; if the delay is > 1 week, loading dose should be repeated.

Dosage with toxicity

Toxicity Type / Counts x 10⁹/L		Toxicity Type / Counts x 10⁹/L	Carboplatin¹	Docetaxel (% previous) ¹
Febrile Neutropenia / Thrombocytopenic bleeding	OR	Grade 4 ANC ≥ 7 d or grade 4 platelets	↓ 1 AUC¹	75%¹
Grade 3 non-hematologic/ organ			↓ 1 AUC¹	75%¹; discontinue if recurs
Grade 4 non-hematologic / organ			Discontinue	Discontinue

_{¹Do not start new cycle until toxicities have recovered to ≤ grade 2, platelets ≥ 100 x 10⁹/L, and ANC ≥ 1.5 x 10⁹/L.}

Trastuzumab:

Product Monograph Recommendations

Trastuzumab should be held with a fall in LVEF (if LVEF falls ≥10 points from baseline and/or if LVEF falls to < 50%). Repeat LVEF in 3 weeks and consider discontinuing. Discontinue if clinically significant cardiac dysfunction or cardiac failure develops.

Canadian Consensus Guidelines

Discontinue if symptomatic.

Management of trastuzumab therapy in adjuvant breast cancer patients with asymptomatic decreases in LVEF (Mackey et al 2008):

Relationship of LVEF to Lower Limit of Normal (LLN)	Trastuzumab dose modification based on asymptomatic LVEF decrease from baseline
Relationship of LVEF to Lower Limit of Normal (LLN)	≤ 10 percentage points	10-15 percentage points	≥ 15 percentage points
Within facility’s normal limits	Continue	Continue	Hold and repeat MUGA/ECHO after 4 weeks
1-5% below LLN	Continue ¹	Hold and repeat MUGA/ECHO after 4 weeks ^{1, 2}	Hold and repeat MUGA/ECHO after 4 weeks ^{2, 3}
≥ 6% below LLN	Continue and repeat MUGA/ECHO after 4 weeks ³	Hold and repeat MUGA/ECHO after 4 weeks ^{2, 3}	Hold and repeat MUGA/ECHO after 4 weeks ^{2, 3}

_{¹ Consider cardiac assessment and starting ACEI therapy}
_{² After 2 holds, consider permanent trastuzumab discontinuation}
_{³ Start ACEI therapy and refer to cardiologist}

Toxicity	Action	Comment
Mild hypersensitivity	Decrease infusion rate	May consider re-challenge with premedication
Hypersensitivity (dyspnea, clinically significant hypotension)	Hold	May consider re-challenge with premedication
Pulmonary toxicity, severe or life-threatening hypersensitivity	Discontinue permanently

Hepatic Impairment

	AST/ALT		Alk Phosp		Bilirubin	Docetaxel (% previous dose)	Carboplatin or Trastuzumab
Mild-moderate	> 1.5 X ULN	AND	> 2.5 x ULN			75%	No change
Severe	> 3.5 x ULN	AND	> 6 x ULN	OR	> ULN	Discontinue	No change

Renal Impairment

Creatinine Clearance (mL/min)	DOCEtaxel (% previous dose)	CARBOplatin (% previous dose)	trastuzumab (% previous dose)
20 - 50	No adjustment appears to be required.	Use Calvert or Chatelut formula (Refer to "Other Notes" section)	No adjustment appears to be required.
<20	No adjustment appears to be required.	Discontinue	No adjustment appears to be required.

F - Adverse Effects

Refer to trastuzumab, DOCEtaxel, CARBOplatin drug monograph(s) for additional details of adverse effects

Most Common Side Effects

Less Common Side Effects, but may be
Severe or Life-Threatening

Headache
Fatigue
Diarrhea (may be severe)
Nausea/vomiting, stomatitis
Musculoskeletal pain
Cardiotoxicity (may be severe)
Infusion-related reaction (may be severe)
Myelosuppression ± infection, bleeding (may be severe)
Fluid retention (may be severe)
Neuropathy (may be severe)
Cutaneous effects (including nails, may be severe)
Alopecia
Lacrimation, tear duct obstruction
Nephrotoxicity (may be severe)
Electrolyte abnormalities

Arterial thromboembolism
Venous thromboembolism
Pancreatitis
Pneumonitis
Arrhythmia
Secondary malignancies
GI obstruction, perforation
Disseminated intravascular coagulation
Hemolytic-uremic syndrome

G - Interactions

Refer to trastuzumab, DOCEtaxel, CARBOplatin drug monograph(s) for additional details

H - Drug Administration and Special Precautions

Refer to trastuzumab, DOCEtaxel, CARBOplatin drug monograph(s) for additional details

I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

Cardiac assessment, including evaluation of left ventricular function (Echocardiogram or MUGA scan); more frequent with asymptomatic reductions in LVEF; baseline, q3 months during treatment, then q6 months after trastuzumab discontinuation x2 years; also as clinically indicated
CBC; baseline and regular
Liver and renal function tests; baseline and routine
Electrolytes (including magnesium); baseline and regular
Clinical toxicity assessment for neurotoxicity, ototoxicity, bleeding, infection, nausea and vomiting, pulmonary toxicity, diarrhea, infusion reactions, fluid retention, cutaneous reactions, thromboembolism, musculoskeletal pain, ophthalmic effects.
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

J - Administrative Information

Approximate Patient Visit

First cycle: 3 to 4 hours; Subsequent cycles: 2 to 3 hours

K - References

Nabholtz JM, Pienkowski T, Northfelt D, et al. Results of two open label multicentre phase II pilot studies with Herceptin in combination with docetaxel and platinum salts (cis or carboplatin) (TCH) as therapy for advanced breast cancer (ABC) in women with tumors over-expressing the HER2-neu proto-oncogene. Eur J Cancer. 2001;37(suppl 6):S190. Abstract 695.

Pegram MD, Pienkowski T, Northfelt DW, et al. Results of Two Open-Label, Multicenter Phase II Studies of Docetaxel, Platinum Salts, and Trastuzumab in HER2-Positive Advanced Breast Cancer. J Natl Cancer Inst 2004; 96: 759–69.

Valero V, Forbes J, Pegram MD, et al. Multicenter phase III randomized trial comparing docetaxel and trastuzumab with docetaxel, carboplatin, and trastuzumab as first-line chemotherapy for patients with HER2-gene-amplified metastatic breast cancer (BCIRG 007 study): two highly active therapeutic regimens. J Clin Oncol 2011;29(2):149-56.

PEBC Advice Documents or Guidelines

The Role of Trastuzumab (Herceptin) in the Treatment of Women with HER2/neu-Overexpressing Metastatic Breast Cancer

October 2017 Removed link to archived PEBC guideline

L - Other Notes

Calvert Formula

DOSE (mg) = target AUC X (GFR + 25)

Target AUC of 4 to 6 mg/mL·min (previously treated patients) or 6 to 8 mg/mL·min (previously untreated patients)
AUC = product of serum concentration (mg/mL) and time (min)
GFR (glomerular filtration rate) expressed as measured Creatinine Clearance or estimated from Serum Creatinine (by Cockcroft and Gault method or Jelliffe method)

^{(Calvert AH, Newell DR, Gumbrell LA, et al, Carboplatin dosage: Prospective evaluation of a simple formula based on renal function. J Clin Oncol, 1989;7:1748-56.)}

Egorin Formula

Previously Untreated Patients-

DOSE (mg/m²) = 317 { ([pre - nadir]/ pre) 100 - 82.1 } X (BSA / Cr Cl) + 447

Previously Treated Patients-

DOSE (mg/m²) = 317 { ([pre - nadir]/ pre) 100 - 92.4 } X (BSA / Cr Cl) + 447

Pre = pretreatment platelet count
Nadir = platelet nadir desired
BSA = Body Surface Area
Cr Cl = Creatinine Clearance

_{(Egorin MJ, Van Echo DA, Tiping SJ, et al, Pharmacokinetics and dosage reduction of carboplatin in patients with impaired renal function. Cancer Res, 1984;44:5432-8.)}

Chatelut Formula

Dose (mg) = Target AUC (mg/mL per min) x Carboplatin clearance (Cl_carboplatin in mL/min)

where Cl(carboplatin) equals to:

{ 218 x wt x (1 – {0.00457 x age}) } x { 1 – (0.314 x gender) }
(0.134 x wt) + -----------------------------------------------------------------------------------
Serum creatinine (µmol/L)

_{wt = Weight in kg}
_{Age (years)}
_{Gender (males = 0; females = 1)}
_{Serum Cr = Serum creatinine (µmol/L)}

_{(Chatelut E, Canal P, Brunner V, et al. Prediction of carboplatin clearance from standard morphological and biological patient characteristics. J Natl Cancer Inst 1995;87(8):573-80.)}

M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
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Regimen Monographs
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Last Updated: July 21, 2026

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