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Deescalation of Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age51+
SponsorUNICANCER

About this trial

Hormone therapy is recommended for five years in all patients with hormone receptor-positive breast cancer, but there is no consensus on its duration in low-risk tumours and especially in postmenopausal women. Adjuvant endocrine therapy (ET) is associated with substantial side effects and long-term decreased quality of life.

Moreover, while it has been shown that ET provides a real benefit in reducing the relapse rate over time, the deterioration in quality of life may also have a negative effect on patient adherence to treatment. It is therefore important to offer treatment to women with low-risk cancer less intensive treatment strategies. If recent trials tested longer durations as compared to 5 years for high-risk cancers, older trials have tested shorter durations. The 5-year duration appeared at that time as the gold standard because of optimal benefit-risk ratios of tamoxifen among high-risk patients. However shorter treatments of 2-3 years were already associated with substantial benefits and may be enough for very low risk patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Prior bilateral oophorectomy

Age ≥60 years

Age >50 and <60 years and amenorrheic for at least 12 months, and follicle-stimulating hormone (FSH) and estradiol in the postmenopausal range

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Disqualifiers

Patients who received a neo-adjuvant hormone therapy, a neo-adjuvant or adjuvant chemotherapy or preoperative medical treatment

Any local or regional recurrence or metastatic disease

Non-invasive carcinoma

Bilateral breast cancer (except in case of contralateral DCIS), or history of other invasive ipsi- or contralateral breast cancer

Trial design

Design model

Single group

Treatments tested in this trial

  • Anti-aromatase inhibitor

    Drug

    Treatment will be either: * Letrozole, given per os, 2.5 mg daily * Anastrozole, given per os, 1 mg daily * Exemestane, given per os, 25 mg daily

Treatment groups

696 Participants
are divided into 1 treatment group
Group A: Aromatase inhibitorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Distant relapse-free interval (DRFI)

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

Time frame
From date of beginning of hormonotherapy to onset of metastases or death, up to 5-years.

Secondary outcomes

1

Distant Disease-Free Survival (DDFS)

DDFS is defined as the time from date of beginning of hormonotherapy to the date of first event of distant recurrence, death from any cause or secondary non-breast cancer.

Time frame
From date of beginning of hormonotherapy to the date of first event of distant recurrence, death from any cause or secondary non-breast cancer up to 10 years
2

Invasive disease free survival (iDFS)

Invasive disease free survival is defined as duration of time from date of registration until first appearance of invasive local, regional, or distant recurrence (including invasive ipsilateral breast cancer recurrence), invasive contralateral breast cancer, second primary non breast invasive cancer (excluding non-melanoma skin cancer), or death from any cause.

Time frame
From date of beginning of hormonotherapy to onset of invasive event, second cancer, or death, up to 10 years.
3

Invasive breast cancer-free survival (iBCFS)

Invasive disease free survival is defined as the delay between date of inclusion and first appearance of invasive local, regional, or distant recurrence (including invasive ipsilateral breast cancer recurrence), invasive contralateral breast cancer, or death from any cause.

Time frame
From date of beginning of hormonotherapy to onset of invasive event or death, up to 10 years.
4

Breast cancer-specific survival (BCSS)

Breast cancer-specific survival is defined as the time from inclusion to death from breast cancer.

Time frame
From date of beginning of hormonotherapy to death from breast cancer, up to 10 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UNICANCER

Lead sponsor

Agendia

Collaborator

Source ClinicalTrials.gov
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