RightFit
Not yet recruitingPhase 2

De-EscaLaTion of Aromatase Inhibitor Therapy: A Randomized Phase II Study of De-escalated Letrozole in Hormone Receptor-Positive Early Breast Cancer

De-EscaLaTion of Aromatase Inhibitor Therapy: A Randomized Phase II Study of De-escalated Letrozole in Hormone Receptor-Positive Early Breast Cancer (DELTA Trial)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 59 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether taking letrozole every other day slows breast cancer cell growth as well as taking it every day. It is for women past menopause with early breast cancer that uses estrogen to grow and is HER2-negative.

This study is a randomized, open-label, phase II trial designed to evaluate whether alternate-day dosing of letrozole preserves antiproliferative activity compared with standard daily dosing in postmenopausal women with estrogen receptor-positive, HER2-negative breast cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and female after menopause. Menopause must meet the study’s rules based on age, periods, removal of both ovaries, or hormone tests.
  • Have stage I–III breast cancer confirmed by a tissue test.
  • The tumor must be estrogen receptor-positive (at least 10%) and HER2-negative, meaning it does not have high levels of the HER2 protein.
  • Plan to have surgery first, and have had no treatment for the current breast cancer.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Have blood cell counts and liver and kidney test results that meet the study’s limits.
  • If you have another past or current cancer, it must not affect study safety or the review of study results.
  • Be able and willing to give written consent. A legally approved representative may give consent for you.

Who can't join

  • Be a candidate for cancer treatment before surgery.
  • Be receiving another experimental drug.
  • Have had an allergic reaction to drugs similar to letrozole.
  • Have an illness that is not controlled or another serious condition that would make the study too risky.
  • Have been male at birth.
  • Have severe osteoporosis (very weak bones), with a bone density T-score below -4 in the spine or hip, or have a broken bone in the spine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participants must have histologically confirmed breast cancer, clinical stage I-III as per the AJCC 8th edition (Anatomic Prognostic Staging). Tumors must be estrogen receptor-positive (ER expression ≥ 10%) and HER2 negative (IHC 0-1+, or IHC 2+ with negative FISH). Tumors can be progesterone receptor positive or negative. Participants must be planned to undergo surgery upfront. Age ≥18 years. Participants must be postmenopausal female. ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A). Participants must have an adequate organ and marrow function as defined below: absolute neutrophil count ≥1,000/mcL platelets ≥100,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. Participants must not have received prior therapy for current breast cancer. Participants must be postmenopausal defined as any of the following: * Age ≥60 years * Age \<60 years with ≥12 months of spontaneous amenorrhea without chemotherapy, endocrine therapy, ovarian suppression, pregnancy, or lactation * Prior bilateral oophorectomy * Age \<60 years with hysterectomy and laboratory values in the postmenopausal range (elevated FSH and low estradiol) Exclusion Criteria: Participants who are candidates for neoadjuvant therapy. Participants who are receiving any other investigation agents. History of allergic reactions attributed to compounds of similar chemical or biologic composition to letrozole. Participants with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous. Male participants at birth History of severe osteoporosis (T score \< -4 either spine or hip), or presence of vertebral fracture.

Study sites (1)

NY