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The anti-proliferative effects of a frankincense extract in a window of opportunity phase ia clinical trial for patients with breast cancer.

  • 2024-01-09
  • Breast cancer research and treatment 204(3)
    • Ingrid V Bonilla Valente
    • Denise Garcia
    • Andrea Abbott
    • Laura Spruill
    • Julie Siegel
    • Jessica Forcucci
    • George Hanna
    • Rupak Mukherjee
    • Mark Hamann
    • Eleanor Hilliard
    • Mark Lockett
    • David J Cole
    • Nancy Klauber-DeMore

Study Design

Type
Clinical Trial
Sample size
n = 18
Population
patients with invasive breast cancer
Methods
Phase Ia window of opportunity trial, B. Serrata (2400 mg/day PO) until the night before surgery for a median of 11 days; non-intervention retrospective control arm
Blinding
Open-label
Duration
for a median of 11 days (SD 6 days; range: 5-23 days)

Purpose

Boswellic acids, active components of frankincense, suppress tumor proliferation in vitro with a strong clinical trial safety profile in patients with inflammatory diseases. We performed a Phase Ia window of opportunity trial of Boswellia serrata (B. serrata) in patients with breast cancer to evaluate its biologic activity and safety.

Methods

Patients with invasive breast cancer were treated pre-operatively with B. Serrata (2400 mg/day PO) until the night before surgery for a median of 11 days (SD 6 days; range: 5-23 days). Paraffin-embedded sections from pretreatment diagnostic core biopsies and post-treatment surgical excisions were evaluated using a tunnel assay and immunohistochemistry staining with Ki-67 antibodies. A non-intervention retrospective control arm consisting of core and surgical tissue specimens from untreated patients was used to compare patients treated with B. Serrata. The change in proliferation and apoptosis between diagnostic core specimens and surgical specimens was compared between the control and treatment groups using a two-tailed paired t-test.

Results

Twenty-two patients were enrolled, of which 20 received treatment, and 18 had sufficient tissue for IHC. There was an increase in percent change in proliferation from core biopsy to surgical excision in the control group (n = 18) of 54.6 ± 21.4%. In the B. serrata-treated group there was a reduction in proliferation between core biopsy and excision (n = 18) of 13.8 ± 11.7%. This difference was statistically significant between the control and B. serrata-treated groups (p = 0.008). There was no difference in change in apoptosis. There were no serious adverse events related to the drug.

Conclusion

Boswellia serrata inhibited breast cancer proliferation and was well-tolerated in a Phase Ia window of opportunity trial.

Research Insights

  • Boswellia→Increased Apoptosis

    There was no difference in change in apoptosis.

    Effect
    Neutral
    Effect size
    Small
    Dose
    2400 mg/day
  • Boswellia→Reduced Breast Cancer Proliferation

    In the B. serrata-treated group there was a reduction in proliferation between core biopsy and excision (n=18) of 13.8 ± 11.7%. This difference was statistically significant between the control and B. serrata-treated groups (p = 0.008).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    2400 mg/day

Adverse Events Reported

  • Boswellia→Overall tolerability

    There were no serious adverse events related to the drug.

    Finding
    Reported
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