Breast Cancer Early Stage Breast Cancer (Stage 1-3)Phase 3DESCENTNCT07153757
De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial
A Phase 3 study testing Endocrine Therapy of Physician's Choice in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Fudan University at 1 site in China.
Trial summary
This study is a prospective, randomized, open-label, non-inferiority Phase III clinical trial, planning to enroll 2,934 patients, with a 1:1 allocation to either the conventional endocrine therapy group or the de-escalation therapy group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- Endocrine Therapy of Physician's Choice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,934 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Sep 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged 18 years or older;
- Postoperative pathological stage I early breast cancer: histologically confirmed invasive carcinoma with a maximum diameter ≤2 cm and node-negative (N0);
- Immunohistochemistry (IHC) shows ER-positive (ER ≥50%), HER2 IHC score of 0, 1+, or 2+ with no amplification confirmed by FISH, and Ki-67 ≤20%;
- Presence of at least one of the following potential low-risk factors:
- 1）Tumor size ≤1 cm, 2）21-gene recurrence score <11, 3）Fudan digital pathological subtype classified as SNF1, 4）Age ≥65 years;
- ECOG performance status of 0 or 1;
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- Patients with bilateral synchronous invasive lesions are eligible if both lesions are ER-positive, HER2-negative, and meet the tumor size criteria;
- Normal major organ function, meeting the following criteria:
- Hematological: HB ≥90 g/L (no transfusion within 14 days), ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L;
- Biochemical: TBIL ≤1.5×ULN, ALT and AST ≤3×ULN, serum Cr ≤1×ULN, and creatinine clearance >50 mL/min (Cockcroft-Gault formula);
- Participants voluntarily enroll, sign informed consent, demonstrate good compliance, and cooperate with follow-up.
Who cannot join
- Primary tumor size >2 cm in maximum diameter and/or axillary lymph node positivity;
- Prior neoadjuvant therapy, any systemic therapy, or local therapy (except surgery), including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy;
- Prior adjuvant chemotherapy;
- Use of CDK4/6 inhibitors in the adjuvant setting;
- History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ);
- Metastasis at any site;
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- Pregnancy, lactation, or women of childbearing potential unable to use effective contraception;
- Concurrent participation in other clinical trials;
- Severe cardiac, pulmonary, hepatic, or renal dysfunction; LVEF <50% (by echocardiography); severe cardio-cerebrovascular diseases within 6 months (e.g., unstable angina, chronic heart failure, uncontrolled hypertension >150/90 mmHg, myocardial infarction, or stroke); poorly controlled diabetes; severe hypertension;
- Severe or uncontrolled infections;
- History of drug abuse or psychiatric disorders;
- Patients deemed unsuitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
270 Dongan Road, Fudan University Shanghai Cancer Center
Shanghai, 200032
About this study
Official title: A Prospective, Randomized, Open-label, Non-inferiority, Phase III Study Evaluating the Efficacy and Safety of 2 to 3 Years of Adjuvant Endocrine De-escalation Therapy for ER-positive/HER2-negative Stage I Breast Cancer
This study is a prospective, randomized, open-label, non-inferiority Phase III clinical trial, planning to enroll 2,934 patients, with a 1:1 allocation to either the conventional endocrine therapy group or the de-escalation therapy group. The aim is to evaluate the safety and efficacy of 2-3 years of de-escalated endocrine therapy in patients with T1N0M0 potentially low-risk breast cancer, respectively.
- Being tested
- Endocrine Therapy of Physician's Choice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocrine Therapy of Physician's ChoiceDrug
This study employs a 2-3 year de-escalated endocrine therapy regimen in the experimental group, which distinguishes it from other escalation therapy studies.
| Study group | Role | What they receive |
|---|---|---|
| 5 years of standard endocrine therapy | Active comparator | The control group receives 5 years of standard endocrine therapy:
Premenopausal patients: Tamoxifen (10 mg, orally, twice daily, for 5 years) or Toremifene (60 mg, orally, once daily, for 5 years); Postmenopausal patients: Letrozole (2.5 mg, orally, once daily, for 5 years) or Anastrozole (1 mg, orally, once daily, for 5 years) or Exemestane (25 mg, orally, once daily, for 5 years); A sequential regimen of 2-3 years of Tamoxifen or Toremifene followed by 3-2 years of Letrozole, Anastrozole, or Exemestane is acceptable.
Ovarian function suppression is permitted for premenopausal patients. CDK4/6 inhibitors are not allowed during the treatment course Receives: Drug: Endocrine Therapy of Physician's Choice |
| 2-3 years of de-escalated endocrine therapy | Experimental | The experimental group receives 2-3 years of endocrine therapy:
Premenopausal patients: Tamoxifen (10 mg, orally, twice daily, for 2-3 years) or Toremifene (60 mg, orally, once daily, for 2-3 years); Postmenopausal patients: Letrozole (2.5 mg, orally, once daily, for 2-3 years) or Anastrozole (1 mg, orally, once daily, for 2-3 years) or Exemestane (25 mg, orally, once daily, for 2-3 years).
Ovarian function suppression is permitted for premenopausal patients. CDK4/6 inhibitors are not allowed during the treatment course. Receives: Drug: Endocrine Therapy of Physician's Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year disease-free survival in the per-protocol population
The proportion of patients in a clinical trial who remained free of disease recurrence, secondary primary cancers, and death from the disease for five years following treatment initiation, calculated specifically among those who completed the study intervention as predefined in the trial protocol(i.e., without major deviations such as incomplete treatment, use of prohibited therapies, or significant protocol violations).
Measured: 5 year
Secondary outcomes (5)
5-year disease-free survival in the Full Analysis Set
The proportion of patients in a clinical trial who remained free of disease recurrence, secondary primary cancers, and death from the disease for five years after randomization or initiation of treatment, analyzed within the Full Analysis Set (FAS) population-which includes all subjects randomized (or initially assigned to a treatment group) following the intention-to-treat (ITT) principle, regardless of whether they fully received, discontinued, or deviated from the protocol.
Measured: 5 year
5-year invasive breast cancer-free survival in the per-protocol population
The proportion of participants in a clinical trial who, after receiving the full intended course of treatment without major protocol deviations, remained free of invasive ipsilateral or contralateral breast cancer recurrence, distant metastatic invasive breast cancer, and death from any cause for a period of five years from the start of treatment or randomization.
Measured: 5 year
Overall survival in the per-protocol population
The length of time from randomization or initiation of treatment until death from any cause, measured specifically among participants who completed the study intervention without major protocol deviations, such as insufficient treatment exposure, use of prohibited therapies, or significant violations of inclusion/exclusion criteria.
Measured: 5 year
Quality of Life score in the per-protocol population
The quality of life of patients was assessed using the EORTC QLQ-C30 questionnaire before, during, and after treatment.
Measured: 5 year
safety
the evaluation of the adverse effects and potential risks of an investigational medical product (e.g., drug, device, or intervention) on participants throughout the study.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2033 (estimated)
- Study completion1 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm#1: 5 years of standard endocrine therapy； Arm#2: 2-3 years of de-escalated endocrine therapy
- Masking
- None (open label)
- Enrolment
- 2,934 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153757
- Sponsor's protocol ID
- SCHBCC-N097
- Acronym
- DESCENT
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-label, Non-inferiority, Phase III Study Evaluating the Efficacy and Safety of 2 to 3 Years of Adjuvant Endocrine De-escalation Therapy for ER-positive/HER2-negative Stage I Breast Cancer
- ClinicalTrials.gov ID
- NCT07153757
- Acronym / sponsor ID
- DESCENT / SCHBCC-N097
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,934 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2033 (estimated)
- Study completion
- 1 Sep 2033 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, randomized, open-label, non-inferiority Phase III clinical trial, planning to enroll 2,934 patients, with a 1:1 allocation to either the conventional endocrine therapy group or the de-escalation therapy group. The aim is to evaluate the safety and efficacy of 2-3 years of de-escalated endocrine therapy in patients with T1N0M0 potentially low-risk breast cancer, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm#1: 5 years of standard endocrine therapy； Arm#2: 2-3 years of de-escalated endocrine therapy
| Arm | Type | Receives |
|---|---|---|
| 5 years of standard endocrine therapy | Active comparator | Drug: Endocrine Therapy of Physician's ChoiceThe control group receives 5 years of standard endocrine therapy: Premenopausal patients: Tamoxifen (10 mg, orally, twice daily, for 5 years) or Toremifene (60 mg, orally, once daily, for 5 years); Postmenopausal patients: Letrozole (2.5 mg, orally, once daily, for 5 years) or Anastrozole (1 mg, orally, once daily, for 5 years) or Exemestane (25 mg, orally, once daily, for 5 years); A sequential regimen of 2-3 years of Tamoxifen or Toremifene followed by 3-2 years of Letrozole, Anastrozole, or Exemestane is acceptable. Ovarian function suppression is permitted for premenopausal patients. CDK4/6 inhibitors are not allowed during the treatment course |
| 2-3 years of de-escalated endocrine therapy | Experimental | Drug: Endocrine Therapy of Physician's ChoiceThe experimental group receives 2-3 years of endocrine therapy: Premenopausal patients: Tamoxifen (10 mg, orally, twice daily, for 2-3 years) or Toremifene (60 mg, orally, once daily, for 2-3 years); Postmenopausal patients: Letrozole (2.5 mg, orally, once daily, for 2-3 years) or Anastrozole (1 mg, orally, once daily, for 2-3 years) or Exemestane (25 mg, orally, once daily, for 2-3 years). Ovarian function suppression is permitted for premenopausal patients. CDK4/6 inhibitors are not allowed during the treatment course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Females aged 18 years or older;
- Postoperative pathological stage I early breast cancer: histologically confirmed invasive carcinoma with a maximum diameter ≤2 cm and node-negative (N0);
- Immunohistochemistry (IHC) shows ER-positive (ER ≥50%), HER2 IHC score of 0, 1+, or 2+ with no amplification confirmed by FISH, and Ki-67 ≤20%;
- Presence of at least one of the following potential low-risk factors:
- 1）Tumor size ≤1 cm, 2）21-gene recurrence score <11, 3）Fudan digital pathological subtype classified as SNF1, 4）Age ≥65 years;
Key exclusion criteria (12 listed)
- Primary tumor size >2 cm in maximum diameter and/or axillary lymph node positivity;
- Prior neoadjuvant therapy, any systemic therapy, or local therapy (except surgery), including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy;
- Prior adjuvant chemotherapy;
- Use of CDK4/6 inhibitors in the adjuvant setting;
- History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endocrine Therapy of Physician's ChoiceThis study employs a 2-3 year de-escalated endocrine therapy regimen in the experimental group, which distinguishes it from other escalation therapy studies. | Drug | 2-3 years of de-escalated endocrine therapy, 5 years of standard endocrine therapy |
Primary outcome
5-year disease-free survival in the per-protocol population
Time frame: 5 year
The proportion of patients in a clinical trial who remained free of disease recurrence, secondary primary cancers, and death from the disease for five years following treatment initiation, calculated specifically among those who completed the study intervention as predefined in the trial protocol(i.e., without major deviations such as incomplete treatment, use of prohibited therapies, or significant protocol violations).
5 secondary outcomes
5-year disease-free survival in the Full Analysis Set
Time frame: 5 year
5-year invasive breast cancer-free survival in the per-protocol population
Time frame: 5 year
Overall survival in the per-protocol population
Time frame: 5 year
Quality of Life score in the per-protocol population
Time frame: 5 year
safety
Time frame: 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Endocrine Therapy of Physician's Choice in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year disease-free survival in the per-protocol population (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.