Evaluation of AryoTrust administration in treatment of breast cancer

Post-marketing surveillance for evaluation of AryoTrust safety in Iranian HER2-positive breast cancer patients under adjuvant chemotherapy regimens

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

IRCT

Registry ID

IRCT20150303021315N16

Enrollment

597

Registered

2019-11-24

Start date

2017-12-22

Completion date

Unknown

Last updated

2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer. Malignant neoplasm of unspecified site of unspecified female breast

Interventions

Intervention group: patients are treated with 6mg/kg trastuzumab (produced by AryoGen pharmed) every 3 weeks in adjuvant setting, for 12 months.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients diagnosed with non-metastatic HER2 positive breast cancer after treatment with adjuvant chemotherapy (trastuzumab in combination with doxetaxel or paclitaxel weekly for 12 weeks or others regimens) who are candidates for trastuzumab maintenance therapy 6 mg/kg every 3 weeks for 12 months

Exclusion criteria

Exclusion criteria: - Patients who received Herceptin - Patients who are not candidates for trastuzumab maintenance therapy after adjuvant chemotherapy

Design outcomes

Primary

Measure	Time frame
Ejection fraction decreased. Timepoint: Every 3 weeks. Method of measurement: echocardiography.;Peripheral oedema. Timepoint: Every 3 weeks. Method of measurement: physical examination.;Tachycardia. Timepoint: Every 3 weeks. Method of measurement: heart rate counting.;Hypotension. Timepoint: Every 3 weeks. Method of measurement: blood pressure meter.;Hypertension. Timepoint: Every 3 weeks. Method of measurement: blood pressure meter.;Nausea- Vomiting- Diarrhoea- Abdominal pain. Timepoint: Every 3 weeks. Method of measurement: medical history and physical examination.;Headache- Fatigue- Insomnia- Dizziness- Paresthesia. Timepoint: Every 3 weeks. Method of measurement: Medical history and physical examination.;Neutropenia- Anaemia- Febrile neutropenia. Timepoint: Every 3 weeks. Method of measurement: CBC complete blood count.;Rash- Nail disorder. Timepoint: Every 3 weeks. Method of measurement: physical examination.;Arthralgia- Bone pain- Back pain. Timepoint: Every 3 weeks. Method of measurement: Medical history and physical examination.;Chills- Pyrexia- Angioedema. Timepoint: Every 3 weeks. Method of measurement: thermometer.;Influenza like illness- Infection. Timepoint: Every 3 weeks. Method of measurement: lab data.	—

Measure

Time frame

Ejection fraction decreased. Timepoint: Every 3 weeks. Method of measurement: echocardiography.;Peripheral oedema. Timepoint: Every 3 weeks. Method of measurement: physical examination.;Tachycardia. Timepoint: Every 3 weeks. Method of measurement: heart rate counting.;Hypotension. Timepoint: Every 3 weeks. Method of measurement: blood pressure meter.;Hypertension. Timepoint: Every 3 weeks. Method of measurement: blood pressure meter.;Nausea- Vomiting- Diarrhoea- Abdominal pain. Timepoint: Every 3 weeks. Method of measurement: medical history and physical examination.;Headache- Fatigue- Insomnia- Dizziness- Paresthesia. Timepoint: Every 3 weeks. Method of measurement: Medical history and physical examination.;Neutropenia- Anaemia- Febrile neutropenia. Timepoint: Every 3 weeks. Method of measurement: CBC complete blood count.;Rash- Nail disorder. Timepoint: Every 3 weeks. Method of measurement: physical examination.;Arthralgia- Bone pain- Back pain. Timepoint: Every 3 weeks. Method of measurement: Medical history and physical examination.;Chills- Pyrexia- Angioedema. Timepoint: Every 3 weeks. Method of measurement: thermometer.;Influenza like illness- Infection. Timepoint: Every 3 weeks. Method of measurement: lab data.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactBanafshe Ghomian

orchid pharmed co

ghomian.b@orchidpharmed.com+98 21 4347 3524

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026