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KISQALI patient portrayal.

MEET KATRICE: She was recently diagnosed with stage III (T2N2) HR+/HER2- eBC

Find out why KISQALI is right for her

KISQALI patient portrayal Katrice.

Katrice is 63 years old and lives a well-rounded life as a daughter, wife, and colleague. She's busy with a DIY home renovation project but stays grounded through a consistent yoga practice and quality time with friends.
 

  • Katrice found a small lump in one of her breasts. She immediately called her primary care doctor, who ordered a mammogram
  • A biopsy confirmed she had HR+/HER2- breast cancer that had spread to her lymph nodes
  • She had a mastectomy and rang the bell after completing chemotherapy; she is now on hormone therapy

Discover more: download Katrice's patient profile.

Katrice’s clinical evaluation

Age

63

Menopausal status

Postmenopausal

Clinical features

  • Size and location: 2.5-cm primary tumor in right breast

  • Nodal involvement: 5 axillary lymph nodes positive for tumor cells

  • Grade: 2

Hormone receptor assay status

ER+/PR+/HER2-

ECOG PS

1

Prior therapy

Mastectomy; adjuvant chemotherapy

Current therapy

Hormone therapy

DIAGNOSIS: Stage III (T2N2) HR+/HER2- eBC

Estimated risk of recurrence for patients with stage III HR+/HER2 - eBC:
Risk of recurrence data reflect recent outcomes published for patients with HR+/HER2- eBC who may be appropriate for treatment with CDK4/6 inhibitors, who were treated with standard ET, including tamoxifen. KISQALI is not indicated for concomitant use with tamoxifen due to an increased risk for QT prolongation.1-3 

3-year risk of recurrence is based on iDFS outcomes among patients with HR+/HER2- eBC who received ET in select CDK4/6 inhibitor clinical trials. Data are from control arms only; no comparisons should be made between results from CDK4/6 inhibitor arms.1,2 

KISQALI consistently reduced the risk of recurrence in the broadest range of patients with stage II/III HR+/HER2- eBC 

Subgroup analysis - In the NATALEE trial, patients like Katrice who had stage 3 disease saw a 25 percent reduction in risk of recurrence. The absolute difference in iDFS values in the stage 3 subgroup was 4.3 percent
The iDFS benefit seen in the stage III subgroup was consistent with the overall population

Results from the subgroup analysis included no prespecified statistical procedure controlling for type 1 error.

iDFS was defined as the time from randomization to the date of the first event of local invasive breast cancer recurrence, regional invasive recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin), or death (any cause).3

NATALEE was a randomized, multicenter, open-label, phase III study of KISQALI + letrozole or anastrozole (n=2549) vs letrozole or anastrozole (n=2552) for the adjuvant treatment of men and women with stage II/III HR+/HER2- eBC. At a median follow-up of 33.3 months, with 509 iDFS (primary end point) events in the study (226 [8.9%] in the KISQALI arm and 283 [11.1%] in the NSAI-alone arm), iDFS at the 3-year landmark was 90.7% for KISQALI + NSAI vs 87.6% for NSAI alone (absolute difference 3.1%); there was a 25.1% relative reduction in the risk of an iDFS event; HR=0.749 (95% CI: 0.628-0.892). At a median follow-up of 33.1 months, iDFS for the prespecified stage III subgroup at the 3-year landmark was 88.1% for KISQALI + NSAI vs 83.8% for NSAI alone; HR=0.755 (95% CI: 0.616-0.926). Prespecified subgroups included anatomic stage (stage II: HR=0.700 [95% CI: 0.496-0.986]; stage III: HR=0.755 [95% CI: 0.616-0.926]), nodal status (N0: HR=0.723 [95% CI: 0.412-1.268]; N1, N2, N3: HR=0.759 [95% CI: 0.631-0.912]), menopausal status (premenopausal/men: HR=0.688 [95% CI: 0.519-0.913]; postmenopausal: HR=0.806 [95% CI: 0.645-1.007]), age (<45 years: HR=0.652 [95% CI: 0.443-0.959]; 45 to 54 years: HR=0.799 [95% CI: 0.578-1.104]; 55 to 64 years: HR=0.871 [95% CI: 0.636-1.193]; ≥65 years: HR=0.662 [95% CI: 0.444-0.986]), and histological grade at time of surgery (grade 1: HR=0.708 [95% CI: 0.303-1.657]; grade 2: HR=0.696 [95% CI: 0.548-0.885]; grade 3: HR=0.890 [95% CI: 0.658-1.204]). Grade 1 subgroup did not include patients with T2N0 disease. Results from the subgroup analysis included no prespecified statistical procedure controlling for type 1 error.3-6

No new safety signals were observed with KISQALI in the adjuvant setting

 

View safety from the NATALEE trial.

REVIEW SAFETY DATA

KISQALI + AI consistently improved iDFS across subgroups, regardless of stage, nodal or menopausal status, age, or grade

 

KISQALI may be right for a variety of patients with stage II/III HR+/HER2- eBC. 

EXPLORE SUBGROUP DATA

KISQALI is approved for patients with stage II/III high-risk node-negative or node-positive HR+/HER2- eBC

 

Regardless of nodal status, tumor size, tumor grade, age (≥18 years), or menopausal status—consider KISQALI for your patients.

NATALEE TRIAL PATIENT POPULATION

Patients with stage IIA, T2N0 HR+/HER2- eBC must meet the following criteria to be eligible for treatment with KISQALI: grade 3, or grade 2 with Ki-67 ≥20% or high genomic risk.6

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Patient Profile: Stage III (T2N2)

Explore Katrice's patient profile to learn why KISQALI may be right for your patients with stage III (T2N2) HR+/HER2- eBC.
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CDK=cyclin-dependent kinase; eBC=early breast cancer; ECOG PS=Eastern Cooperative Oncology Group performance status; ER+=estrogen receptor-positive; ET=endocrine therapy; HR=hazard ratio; iDFS=invasive disease-free survival; NSAI=nonsteroidal aromatase inhibitor; PR+=progesterone receptor-positive. 
 
References: 1. Mayer EL, Dueck AC, Martin M, et al. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2021;22(2):212-222. doi:10.1016/S1470-2045(20)30642-2 2. Johnston SRD, Toi M, O’Shaughnessy J, et al. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023;24(1):77-90. doi:10.1016/S1470-2045(22)00694-5 3. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp 4. Hortobagyi GN, Stroyakovskiy D, Yardley DA, et al. Ribociclib + nonsteroidal aromatase inhibitor as adjuvant treatment in patients with HR+/HER2- early breast cancer: final invasive disease-free survival analysis from the NATALEE trial. Presented at: San Antonio Breast Cancer Symposium; December 5-9, 2023; San Antonio, TX. 5. Data on file. CLEE011O12301C (NATALEE) final iDFS analysis results. Novartis Pharmaceuticals Corp; 2023. 6. Slamon DJ, Fasching PA, Hurvitz S, et al. Rationale and trial design of NATALEE: a phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2− early breast cancer. Ther Adv Med Oncol. 2023;15:1-16. doi:10.1177/17588359231178125