Phase 4
N=40
RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF
Breast Cancer · Infertility
Bottom Line
View on ClinicalTrials.gov: NCT01035099 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Mature Oocyte Yield — 5.1; 7.9 oocytes — p=0.31
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Letrozole (Drug)
- Age
- Adult · 19+ yrs
- Sex
- Female
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mature Oocyte Yield |
5.1; 7.9 | 0.31 |
| PRIMARY Percent of Mature Oocyte Yield |
0.29; 0.46 | 0.19 |
| SECONDARY Participant Cycle Cancellation Rate |
— | — |
| SECONDARY Breast Cancer Recurrence Rate |
— | — |
| SECONDARY Peak Serum Estradiol Level |
603.1; 771.1 | 0.12 |
| SECONDARY FSH ng/ml (Cycle Day 2) |
5.9; 5.8 | 0.77 |
| SECONDARY AMH ng/ml (Cycle Day 2) |
2.1; 2.4 | 0.63 |
| SECONDARY AF Count |
— | — |
| SECONDARY Total Days Stimulation Medications |
10.1; 11.2 | 0.14 |
| SECONDARY Total Medication Dose |
34.0; 55.3 | <0.0001 sig |
| SECONDARY Total Number of Oocytes |
17.1; 19.0 | 0.58 |
| SECONDARY Number of Follicles on Day of HCG |
— | — |
| SECONDARY Number of Fertilized Oocytes |
3.7; 5.3 | 0.42 |
| SECONDARY Number of Good Quality Embryos |
— | — |
| SECONDARY Breast Cancer Recurrence at Year 1-2 |
— | — |
| SECONDARY Breast Cancer Recurrence at Year 2-3 |
— | — |
Summary
The purpose of this study is to compare two different ways to administer Letrozole to determine their effectiveness in blocking estrogen production during ovarian stimulation in patients with breast cancer prior to chemotherapy/radiotherapy so that oocytes or embryos can be cryopreserved and patients can possibly achieve a pregnancy after the treatment of breast cancer.
During standard ovulation stimulation, the estrogen levels will exceed normal levels and may reach 10 times the normal level for a 2 week period. This may not be desirable in breast cancer patients. The study hopes to determine if the investigators can stimulate oocyte development in the conventional way and administer different doses of Letrozole as the oocytes develop, to keep estradiol levels low, increase the number of oocytes the investigators are able to recover, and improve the quality of those oocytes.
Eligibility Criteria
Inclusion Criteria
- Female breast cancer patient with breast cancer diagnosis after surgery and before undergoing chemotherapy desiring fertility preservation with oocyte or embryo cryopreservation
- Healthy subject according to documented medical history and physical examination who has been diagnosed with breast cancer (estrogen and progesterone receptor positive and/or negative)
- Age less that 45 years at time of informed consent
- Verbal or written clearance from medical or surgical oncologist to undergo controlled ovarian hyperstimulation-IVF
- Delay to chemotherapy treatment will not jeopardize cancer treatment outcome
- Ovarian stimulation will not affect cancer treatment plan
- Transvaginal ultrasound scan (US) within one month of starting stimulation with no clinically significant pelvic mass
- Serum FSH level (Day 2-4) less than 25
- Negative pregnancy test prior to beginning Letrozole or gonadotropin therapy
- Willing and able to comply with the protocol
- Voluntary provision of written informed consent, prior to any study related procedure that was not part of normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to her future medical care
- Willingness to provide follow-up information on herself and babies born as part of this study
Exclusion Criteria
- Patients not medically cleared by their oncologist
- Patients with stage IV breast cancer based on the poor prognosis, general health of the patient, and higher uncertainty with delaying chemotherapy
- Any clinically relevant abnormal laboratory value (FSH >25 miu/ml, renal function, (greater than two times normal value), hepatic function (greater than two times normal value), blood biochemistry, hematology (elevated white blood count greater than 1.5 times the normal value, hemoglobin <10mg/dL, thrombocytopenia), abnormal cholesterol profile (total cholesterol ≥ 300mg/dL, abnormal LDL greater than 2 times normal value,) based on a fasting sample during the screening phase
- Contraindications for the use of gonadotropins (i.e. Tumors other than breast cancer, pregnancy, lactation, undiagnosed vaginal bleeding)
- Recent or current medical conditions where the patient is not medically stable to undergo stimulation or egg retrieval, HIV infection, diabetes, cardiovascular disease, gastrointestinal, hepatic disease, undiagnosed pelvic mass, renal or pulmonary disease
- History or presence of alcohol or drug abuse within 12 months of signing consent
- History of severe allergic or anaphylactic reactions or hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol
- Administration of investigational drugs within three months prior to signing the informed consent
- Use of insulin sensitizing agents at least one month prior to signing informed consent
- Any patient who is not a candidate for IVF
Data sourced from ClinicalTrials.gov (NCT01035099). 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.