Correlation analysis of HIF-1a and CA15-3 in response to neoadjuvant chemotherapy in locally advanced breast cancer

Correlation analysis of HIF-1a and CA15-3 in response to neoadjuvant chemotherapy in locally advanced breast cancer: a cohort study in Indonesia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN63220723

Enrollment

Registered

2021-09-07

Start date

2021-07-01

Completion date

Unknown

Last updated

2021-09-20

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

Conditions

Locally advanced breast cancer Cancer Malignant neoplasm of breast

Interventions

Lesion measurement All measurements are recorded in matrix notation using a clinical caliper. All baseline measurements were taken at the start of therapy or within 4 weeks of treatmen

Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of the target lesion, with the baseline sum LD as the reference

Progressive Disease (PD): At least a 20% increase in the sum of the LD of the target lesion, with the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the treatment started. H

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. LABC with a histopathologically confirmed diagnosis of invasive ductal carcinoma 2. NAC regimen of cisplatin (80 mg/BSA) and gemcitabine (1,000 mg/BSA) in two cycles 3. Karnofsky Performance Status Scale >70%

Exclusion criteria

Exclusion criteria: 1. Receiving chemotherapy with radiotherapy 2. Bilateral BC 3. Abnormal hematological parameters 4. Changes in chemotherapy regimen 5. Patients with an inherited metabolic disorder or comorbidities resulting in delayed chemotherapy 6. Acute or chronic obstructive pulmonary disease with SpO2 under 96%

Design outcomes

Primary

Measure	Time frame
HIF-1a and CA15-3 serum levels measured using ELISA at baseline and after receiving two cycles of NAC (Neoadjuvant chemotherapy) in a period of 5 weeks	—

Secondary

Measure	Time frame
Lesion measurement recorded in matrix notation using a clinical caliper and evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at baseline and after receiving two cycles of NAC (Neoadjuvant chemotherapy) in a period of 5 weeks	—

Countries

Indonesia

Outcome results

None listed

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