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Phase 3 Completed N=2,672 Randomized Treatment

Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

Source: ClinicalTrials.gov NCT00066703 ↗
Enrolled (actual)
2,672
Serious AEs
37.2%
Results posted
Apr 2016
Primary outcomePrimary: Disease-free Survival — 87.3; 91.1 percentage of participants — p=.0002
◆ Published Evidence
Highly cited
746citations · ~62 / year
Adjuvant exemestane with ovarian suppression in premenopausal breast cancer.
The New England journal of medicine · 2014 · Open access · High-confidence link

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer. PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.

Linked Publications (5)

  • Adjuvant exemestane with ovarian suppression in premenopausal breast cancer.
    The New England journal of medicine · 2014 · 746 citations · Open access · High-confidence link
  • Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 · 153 citations · Open access · High-confidence link
  • Absolute Improvements in Freedom From Distant Recurrence to Tailor Adjuvant Endocrine Therapies for Premenopausal Women: Results From TEXT and SOFT.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020 · 150 citations · Open access · Likely link
  • Identifying premenopausal patients with early-stage hormone receptor-positive breast cancer at minimal risk of distant recurrence by breast cancer index.
    Breast (Edinburgh, Scotland) · 2026 · 0 citations · Open access · Likely link
  • Prognostic value of patient-reported depression in women with hormone-responsive early breast cancer in TEXT and SOFT.
    Cancer · 2025 · 0 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Disease-free Survival
87.3; 91.1 .0002 sig
SECONDARY
Breast Cancer-free Interval
88.8; 92.8 <.0001 sig
SECONDARY
Distant Recurrence-free Interval
92.0; 93.8 0.02 sig
SECONDARY
Overall Survival
93.3; 93.4 0.84

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer
  • Completely resected disease
  • No clinically detectable residual loco-regional axillary disease
  • Prior surgery for primary breast cancer of 1 of the following types:
  • Total mastectomy with or without adjuvant radiotherapy
  • Breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins negative* for invasive disease and ductal carcinoma in situ) with planned radiotherapy NOTE: *If all other margins are clear a positive posterior (deep) margin is permitted, provided the excision was performed down to the pectoral fascia and all tumor has been removed OR a positive anterior (superficial; abutting skin) margin is allowed provided all tumor was removed
  • Tumor confined to the breast and axillary nodes
  • Tumor detected in internal mammary chain nodes by sentinel node procedure and is not enlarged is allowed
  • Axillary lymph node dissection or a negative axillary sentinel node biopsy required
  • Patients with negative or microscopically positive axillary sentinel nodes are eligible
  • Positive sentinel nodes must have either axillary dissection or radiation of axillary nodes
  • No distant metastases
  • No locally advanced inoperable breast cancer, including any of the following:
  • Inflammatory breast cancer
  • Supraclavicular node involvement
  • Enlarged internal mammary nodes (unless pathologically negative)
  • Bilateral synchronous invasive breast cancer allowed if disease meets all other eligibility criteria
  • No prior ipsilateral or contralateral invasive breast cancer
  • Hormone receptor status:
  • Estrogen and/or progesterone receptor positive
  • At least 10% of the tumor cells positive by immunohistochemistry
  • If > 1 breast tumor, each tumor must be hormone receptor positive

PATIENT CHARACTERISTICS:

Age

  • Premenopausal

Sex

  • Female

Menopausal status

  • Premenopausal
  • Estradiol in the premenopausal range after prior surgery OR meets the following criteria:
  • Menstruating regularly for the past 6 months
  • Has not used any form of hormonal treatment (including hormonal contraception) within the past 6 months

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • No systemic hepatic disease that would preclude prolonged follow-up

Renal

  • No systemic renal disease that would preclude prolonged follow-up

Cardiovascular

  • No systemic cardiovascular disease that would preclude prolonged follow-up
  • No prior thrombosis (e.g., deep vein thrombosis) and/or embolism unless patient is medically suitable

Pulmonary

  • No systemic pulmonary disease that would preclude prolonged follow-up

Other

  • Not pregnant or nursing
  • Fertile patients must use effective nonhormonal contraception
  • No history of noncompliance to medical regimens
  • No other nonmalignant systemic disease that would preclude prolonged follow-up
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ, contralateral or ipsilateral carcinoma in situ of the breast, or other nonrecurrent invasive nonbreast malignancy, including any of the following:
  • Stage I papillary thyroid cancer
  • Stage IA carcinoma of the cervix
  • Stage IA or B endometrioid endometrial cancer
  • Borderline or stage I ovarian cancer
  • No psychiatric, addictive, or other disorder that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior or concurrent neoadjuvant or adjuvant trastuzumab allowed

Chemotherapy

  • No prior neoadjuvant or adjuvant chemotherapy

Endocrine therapy

  • No prior tamoxifen, other selective estrogen-receptor modulators (SERMs) (e.g., raloxifene), or hormone replacement therapy for more than 1 year before breast cancer diagnosis
  • No prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer
  • No concurrent oral or transdermal hormonal therapy
  • No other concurrent estrogen, p
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00066703) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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