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Войти в исследования European journal of cancer (Oxford, England : 1990) · 2026
Combined pharmacologic and lifestyle intervention for breast cancer prevention: Results of the randomized phase II TOLERANT trial in high-risk women.
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Serrano Davide, Lazzeroni Matteo, Rizzo Roberta, Gnagnarella Patrizia, Aurilio Gaetano, Colombo Elisa, Guerrieri-Gonzaga Aliana, Johansson Harriet, Zovato Stefania, Nardi Mariateresa, Matteraglia Anna, Pensabene Matilde, Buccolo Simona, Pistelli Luigi, Giancarli Giorgia, Carbone Alessio, Aristarco Valentina, Macis Debora, Accornero Chiara A, Merli Davide, Salè Emanuela Omodeo, DeCensi Andrea, Gandini Sara, Bonanni Bernardo
Аннотация
BACKGROUND: Breast cancer (BC) prevention strategies include lifestyle modification and preventive agents such as selective estrogen receptor modulators and aromatase inhibitors. Sex hormone-binding globulin (SHBG) is a breast cancer risk-associated biomarker; however, it is not a validated surrogate endpoint for breast cancer risk reduction.
METHODS: Population: women with hereditary BC risk, a ≥ 5% 10-year BC risk, or a history of intraepithelial neoplasia were enrolled.
TRIAL DESIGN: a four-arm randomized phase II biomarker trial: Tamoxifen 10 mg every other day (LDT); LDT + Intermittent Caloric Restriction (ICR); Lifestyle intervention with a step counter (LI); LI + ICR.
PRIMARY ENDPOINT: Post intervention levels of circulating SHBG. Secondary endpoints: modulation of IGF system, adipokines, inflammatory markers, quality of life. Main analysis was LDT+ ICR vs LI+ICR.
RESULTS: One hundred and ten participants were randomized to: LDT, LDT plus ICR, LI, or LI plus ICR, for 6 months. Mean age was 52 years and mean BMI was 25 kg/m²; 62% were unaffected carriers, and 65% were postmenopausal. LDT±ICR significantly increased SHBG and IGFBP-3 and decreased IGF-I (absolute change p < 0.0001, p = 0.004, and p < 0.001, respectively). ICR arms showed higher adiponectin than non-ICR arms (p = 0.003). Furthermore, in adherent subjects (>90%), LI plus ICR was significantly associated with higher SHBG compared with LI alone (p = 0.045). No differences in adverse events between arms; LDT demonstrated a mild, although significant, worsening in quality of life.
CONCLUSIONS: LDT favorably modulates BC risk-associated biomarkers, and ICR adds a complementary metabolic effect, supporting further investigation of these combined strategies.
METHODS: Population: women with hereditary BC risk, a ≥ 5% 10-year BC risk, or a history of intraepithelial neoplasia were enrolled.
TRIAL DESIGN: a four-arm randomized phase II biomarker trial: Tamoxifen 10 mg every other day (LDT); LDT + Intermittent Caloric Restriction (ICR); Lifestyle intervention with a step counter (LI); LI + ICR.
PRIMARY ENDPOINT: Post intervention levels of circulating SHBG. Secondary endpoints: modulation of IGF system, adipokines, inflammatory markers, quality of life. Main analysis was LDT+ ICR vs LI+ICR.
RESULTS: One hundred and ten participants were randomized to: LDT, LDT plus ICR, LI, or LI plus ICR, for 6 months. Mean age was 52 years and mean BMI was 25 kg/m²; 62% were unaffected carriers, and 65% were postmenopausal. LDT±ICR significantly increased SHBG and IGFBP-3 and decreased IGF-I (absolute change p < 0.0001, p = 0.004, and p < 0.001, respectively). ICR arms showed higher adiponectin than non-ICR arms (p = 0.003). Furthermore, in adherent subjects (>90%), LI plus ICR was significantly associated with higher SHBG compared with LI alone (p = 0.045). No differences in adverse events between arms; LDT demonstrated a mild, although significant, worsening in quality of life.
CONCLUSIONS: LDT favorably modulates BC risk-associated biomarkers, and ICR adds a complementary metabolic effect, supporting further investigation of these combined strategies.