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CA 15-3 (Cancer Antigen 15-3)

SI UNITS (recommended)

CONVENTIONAL UNITS

(Mucin-1 Glycoprotein Fragment – Tumor Marker for Breast Cancer)

Synonyms

  • CA 15-3
  • Cancer Antigen 15-3
  • MUC1 antigen fragment
  • Breast cancer marker
  • DF3 antigen

Units of Measurement

  • U/mL (Units per milliliter - standard)
  • kU/L (kilo-units per liter)

1 U/mL = 1 kU/L

Description

CA 15-3 is a circulating fragment of the transmembrane glycoprotein Mucin-1 (MUC1).
It is shed into the bloodstream from breast epithelial cells, especially in breast carcinoma.

Major clinical use:

  • Monitoring breast cancer treatment and recurrence
  • Not recommended for average-risk screening or early diagnosis

CA 15-3 is elevated in:

  • Metastatic breast cancer (highest)
  • Some early-stage breast cancers
  • Certain benign conditions

Physiological Source

Produced by:

  • Breast ductal epithelial cells
  • Normal epithelial cells of lung, ovary, GI tract (low amounts)

Tumor cells overexpress MUC1, releasing larger quantities of CA 15-3.

Clinical Significance

Elevated CA 15-3

1. Breast Cancer (Most Important Use)

  • Levels correlate with disease burden
  • Most sensitive in metastatic disease
  • Used to:
    • Track treatment response
    • Detect recurrence
    • Monitor metastatic spread (bone/liver)

2. Benign Breast / Gynecologic Conditions

May cause mild elevations:

  • Benign breast disease
  • Endometriosis
  • Pregnancy
  • Ovarian cysts
  • Mastitis

3. Non-Breast Malignancies

Moderate CA 15-3 elevation may occur in:

  • Ovarian cancer
  • Pancreatic cancer
  • Lung cancer
  • Liver cancer
  • GI cancers

4. Liver Disease

Decreased clearance → increased CA 15-3.

Low CA 15-3

Normal; no clinical concern.

Reference Intervals

(Tietz 8E + NCCN + Mayo + ARUP)

Normal Range

  • < 30 U/mL
  • (Some labs use <25 U/mL)

Interpretation

  • 30–60 U/mL → Mild elevation (often benign or early disease)
  • > 60–100 U/mL → Concerning; consider metastatic disease
  • > 100 U/mL → Strongly suggests advanced/metastatic breast cancer

Monitoring

  • Falling CA 15-3 → good therapeutic response
  • Rising trend → recurrence or metastasis
    (Trend is more important than any single value.)

Unit Meanings

UnitMeaning
U/mLUnits per milliliter
kU/Lkilo-units per liter

Diagnostic Uses

1. Monitoring Breast Cancer Treatment

  • Chemotherapy
  • Hormonal therapy
  • Targeted therapy (HER2 drugs)

2. Recurrence Surveillance

  • CA 15-3 rises months before clinical detection in many patients.

3. Evaluating Metastatic Spread

Especially in:

  • Liver metastases
  • Bone metastases

4. Adjunct in Diagnostic Workup

Not diagnostic alone, but used alongside:

  • Imaging (US/Mammography/MRI/PET)
  • Histopathology
  • Other markers (CEA, CA 27-29)

Analytical Notes

  • Method: immunoassay (chemiluminescence/electrochemiluminescence)
  • Avoid interpretation in pregnancy (can elevate).
  • Liver dysfunction may increase levels.
  • Serial testing should use same assay platform for consistency.
  • Hemolysis/lipemia → minimal effect.

Clinical Pearls

  • CA 15-3 is not recommended for breast cancer screening.
  • Best utility → monitoring metastatic disease, not early detection.
  • Rapid increase = recurrence; slow increase = disease progression.
  • Combination with CEA improves sensitivity in metastatic breast cancer.
  • CA 15-3 can remain normal in 30–50% of early-stage breast cancers.

Interesting Fact

MUC1, the parent glycoprotein of CA 15-3, is overexpressed in most epithelial cancers and is being used in developing personalized cancer vaccines.

References

  1. Tietz Clinical Chemistry & Molecular Diagnostics, 8th Edition - Tumor Markers.
  2. NCCN Guidelines Breast Cancer.
  3. ASCO Tumor Marker Guidelines.
  4. IFCC - Tumor Marker Standardization.
  5. Mayo Clinic Laboratories - CA 15-3.
  6. ARUP Consult - Breast Cancer Markers.
  7. MedlinePlus / NIH - Tumor Marker Overview.

Last updated: January 26, 2026

Reviewed by : Medical Review Board

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