Reduction of hormone therapy duration in women with hormonesensitive breast cancer at very low risk of metastatic recurrence

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Unicancer

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

12 Oct 2022 → ongoing

Decision date (initial)

2024-06-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514480-26-00

EudraCT number

2021-002889-41

ClinicalTrials.gov

NCT05297617

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To prospectively demonstrate that an adjuvant aromatase inhibitor therapy duration limited to 2 years is associated with high distant recurrence-free interval (DRFI) at 5 years in a selected population with invasive breast cancer at low risk of metastatic recurrence.

Secondary objectives 8

1. Evaluate Invasive Disease-Free Survival (iDFS)
2. Evaluate Invasive breast cancer-free survival (iBCFS)
3. Evaluate breast cancer specific survival (BCSS)
4. Evaluate overall survival (OS)
5. Assess quality of life (QoL) at baseline and every year until 5 years after the start of the study in term of general QoL, fatigue, psychological, geriatric characteristics ( in patients aged >=75years) and cognitive functions
6. Evaluate the safety of the treatment in the study population
7. Describe DRFI, DDFS, iDFS, iBCFS, BCSS and OS of patients who are not at “ultra-low” risk (low risk or high risk) according to Mammaprint® test performed for the study screening
8. Evaluate Distant Disease-Free Survival (DDFS)

Conditions and MedDRA coding

Post-menopausal women with localized luminal A breast cancer and considered at low risk of metastatic relapse

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

1. Postmenopausal women: Postmenopausal status is defined by any of the following: - Prior bilateral oophorectomy - Age ≥60 years - Age >50 and <60 years and amenorrheic for at least 12 months, and folliclestimulating hormone (FSH) and estradiol in the postmenopausal range
2. Patients eligible to receive or have recently started (with a maximum of 4 months of adjuvant hormone therapy prior to enrollment) an adjuvant hormone therapy (letrozole, anastrozole, or exemestane)
3. Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures
4. Patients must be affiliated to a Social Security System (or equivalent)
5. Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
7. Women with histologically proven invasive unilateral breast cancer
8. M0: Not clinically nor radiologically detectable metastases at time of inclusion
9. Primary tumor completely resected and adequate axillary surgery performed, according to current standards
10. IHC expression of the estrogen receptor and/or progesterone receptor ≥50%
11. HER2 negative according to ASCO criteria in immunohistochemistry and/or genomic analysis (HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH nonamplified])
12. No indication of adjuvant chemotherapy
13. Patient considered has having a luminal A ultralow risk of metastatic recurrence (i.e. less than 5% risk of metastatic relapse at 10 years) according to MammaPrint® and Blueprint® tests.
14. pT1 (tumor ≤20 mm), pN0, Grade 1 or Grade 2 OR pT2 (tumor ≤30 mm) and pN0, Grade 1 or Grade 2

Exclusion criteria 11

1. Patients who received a neo-adjuvant hormone therapy, a neo-adjuvant or adjuvant chemotherapy or preoperative medical treatment
2. Any local or regional recurrence or metastatic disease
3. Non-invasive carcinoma
4. Bilateral breast cancer (except in case of contralateral DCIS), or history of other invasive ipsi- or contralateral breast cancer
5. Patients with a history of another malignancy without complete remission for more than 5 years, except for properly treated cervical carcinoma in situ and non-melanoma cancer of the skin
6. Women with high-risk breast cancer predisposing deleterious germline mutations
7. Contra-indications to the administration of anti-aromatase inhibitors
8. Patients enrolled in another therapeutic study within 30 days of inclusion
9. Patients with any other disease or illness, which requires hospitalization or is incompatible with the trial treatment
10. Patients unwilling or unable to comply with trial obligations for geographic, social, physical or psychological reasons, or who are unable to understand the purpose and procedures of the trial
11. Persons deprived of their liberty or under protective custody or guardianship

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Distant relapse–free interval (DRFI) defined as the time from date of beginning of hormonotherapy to the date of first event of distant recurrence or breast cancer related death.

Secondary endpoints 7

1. Invasive disease-free survival (iDFS)
2. Invasive breast cancer–free survival (iBCFS)
3. Breast cancer specific survival (BCSS)
4. Overall survival (OS)
5. Quality of life
6. Safety: Adverse Events will be graded according to NCI-CTCAE v5.0
7. Distant Disease-Free Survival (DDFS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Unicancer

Sponsor organisation

Unicancer

Address

101 Rue De Tolbiac

City

Paris

Postcode

75013

Country

France

Scientific contact point

Organisation

Unicancer

Contact name

Nourredine AIT RAHMOUNE

Public contact point

Organisation

Unicancer

Contact name

Nourredine AIT RAHMOUNE

Locations

1 EU/EEA country · 50 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications