Clinical trial · Observational

Endocrine Therapy Base on 21-gene RS

Comparison of Endocrine Therapy Plus Ovarian Function Suppression and Chemotherapy Based on 21-gene RS in Young Age (≤ 50) Women (CUSTOM): Multi-center Registry Study

NCT07311122CI-TRIAL-00099859CUSTOMnot yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Among patients aged ≤50 years with hormone receptor-positive, HER2-negative breast cancer and pathologic nodal stage pN0-1-limited to those with an Oncotype DX® Recurrence Score (RS) of 11-25 for pN0 and ≤25 for pN1-, we will investigate the followings: i) Real-world patterns of adjuvant therapy (systemic chemotherapy and endocrine therapy) and radiotherapy according to N stage and Oncotype DX® RS. ii) Clinicopathologic characteristics of each patient subgroup by adjuvant treatment modality and RS category. iii) Survival outcomes and independent prognostic factors according to RS. iv) Survival analyses by adjuvant treatment modality, stratified by RS category, clinical risk, and N stage. Through these analyses, we aim to establish clinical evidence on whether endocrine therapy combined with ovarian function suppression (OFS) can substitute for adjuvant chemotherapy in HR+/HER2- patients with pN0-1 disease within the above RS ranges, and-if so-to define the patient subsets for whom this substitution is appropriate.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Oncotype DX	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
invasive disease-free survival
timeFrame
5 years after breast cancer diagnosis

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 20 Years

Show eligibility criteria text

Inclusion Criteria:

1. Histologically confirmed breast cancer.
2. Age ≤50 years at initial diagnosis.
3. Premenopausal at diagnosis, defined as any of the following:

A. History of menstruation within 6 months prior to diagnosis. B. Serum FSH \< 30 mIU/mL. C. If criteria A or B are unavailable, women aged ≤50 years are considered premenopausal.
4. Underwent curative-intent breast cancer surgery between January 2012 and December 2021.
5. Pathologic tumor stage pT1-pT3 after surgery.
6. Pathologic nodal stage pN0-pN1 after surgery.
7. Hormone receptor-positive disease by immunohistochemistry (IHC): estrogen receptor (ER) and/or progesterone receptor (PR) positive (≥1% positive cells or Allred score ≥3).
8. HER2-negative disease per ASCO/CAP guidelines: IHC 0 or 1+; if IHC 2+, in situ hybridization (FISH or SISH) negative.
9. Oncotype DX® performed, meeting one of the following Recurrence Score (RS) ranges:

A. pN0: RS 11-25. B. pN1: RS ≤25.

Exclusion Criteria:

1. Evidence of distant (systemic) metastasis at diagnosis.
2. Postmenopausal status at diagnosis, defined as any of the following:

A. Prior bilateral oophorectomy before the breast cancer diagnosis (considered postmenopausal).

B. Prior unilateral oophorectomy alone is not considered postmenopausal (classified as premenopausal).

C. Bilateral oophorectomy performed after breast cancer surgery for therapeutic purposes is not an exclusion; such patients will be categorized as having received ovarian function suppression (OFS).

D. Serum FSH ≥ 30 mIU/mL.
3. Hormone receptor-negative or HER2-positive disease.
4. Insufficient or unclear data regarding the type of adjuvant therapy received.
5. History of another malignancy treated before the breast cancer diagnosis, except for thyroid cancer and non-melanoma skin cancer.
6. Bilateral breast cancer.
7. Receipt of neoadjuvant systemic therapy prior to surgery.

References

Publications (0)

Data not yet available

No reference posted for this study.