Pembrolizumab
Immunotherapy
Immune inflammation of bowel, lungs, liver, kidneys or skin
Hormone-gland problems, sometimes permanent
Rare serious heart or neurological inflammation
Infusion reaction
Effects can first appear after treatment ends
SACTCHECK · REGIMEN-SPECIFIC SACT CONSENT
Pembrolizumab 200 mg + carboplatin AUC 5 / paclitaxel → AC
Triple-negative breast cancer · neoadjuvant and adjuvant immunotherapy · NCCP 00857 · version 3 · 21-day cycle
PROTOTYPE · GOVERNANCE REVIEW REQUIRED
Patient name
DOB
Hospital no.
Date
Treatment context
Treat the cancer before surgery as part of a plan intended to reduce the risk of it returning.
Treat the cancer before surgery as part of a plan intended to reduce the risk of it returning.
Schedule
Phase 1: four 21-day cycles; paclitaxel on Days 1, 8 and 15, carboplatin on Day 1. Phase 2: four AC cycles every 21 days. Pembrolizumab 200 mg every 21 days during chemotherapy; after surgery, nine 21-day doses or five 42-day doses (400 mg). See the whole-treatment map for monitoring and sequencing.
Phase 1: four 21-day cycles; paclitaxel on Days 1, 8 and 15, carboplatin on Day 1. Phase 2: four AC cycles every 21 days. Pembrolizumab 200 mg every 21 days during chemotherapy; after surgery, nine 21-day doses or five 42-day doses (400 mg). See the whole-treatment map for monitoring and sequencing.
1. Treatment discussion
Purpose, expected benefit and alternatives explained
Platinum/taxane and AC phases explained
Surgery and postoperative plan discussed
Separate supportive prescriptions and growth-factor plan agreed
Blood tests, ECG / cardiac and imaging checks explained
Fertility, contraception and pregnancy precautions discussed
Common, serious and lasting medicine-specific risks discussed below
Questions and the individual consent discussion recorded
2. Regimen / agent-specific material risks
Carboplatin
Platinum chemotherapy
Low blood counts, infection and bleeding
Nausea, vomiting and fatigue
Allergic reaction, sometimes after previous exposure
Kidney or electrolyte changes
Paclitaxel
Taxane chemotherapy
Low blood counts and infection
Numbness / tingling, sometimes lasting
Hair loss, muscle or joint pain
Infusion reaction
Mouth, bowel, skin and nail effects
Doxorubicin
Anthracycline chemotherapy
Low counts, infection and mouth ulcers
Nausea, hair loss and fatigue
Heart damage, sometimes delayed
Severe tissue injury if the infusion leaks
Rare later blood cancers
Cyclophosphamide
Alkylating chemotherapy
Low counts and infection
Nausea, vomiting and hair loss
Bladder irritation / bleeding
Fertility effects and menopause
Rare later blood cancers
Individual aim / benefit, alternatives, material risks and questions:
3. Consent confirmation
Expected benefit, important risks and reasonable alternatives discussed
Patient questions invited and answered; patient-specific material risks / priorities considered
Emergency contact / toxicity advice and written information offered where appropriate
Patient understands consent is voluntary and may be withdrawn
Patient / person giving consent
Date
Clinician obtaining consent
Date