309 Participants Needed

Tamoxifen + Letrozole for Fertility Preservation in Breast Cancer

(TALES Trial)

AW
RW
Overseen ByRebecca Wong
Age: 18 - 65
Sex: Female
Trial Phase: Phase 3
Sponsor: University of California, San Francisco
Must be taking: Letrozole, Tamoxifen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves ovarian stimulation and oocyte retrieval, it's best to discuss your current medications with the trial team or your doctor.

What data supports the idea that Tamoxifen + Letrozole for Fertility Preservation in Breast Cancer is an effective drug?

The available research shows that letrozole, when compared to tamoxifen, improves the chances of staying free from breast cancer for longer periods in postmenopausal women. Letrozole is also better at preserving the breast during treatment. Additionally, a specific protocol using letrozole with tamoxifen has been developed for fertility preservation in women with breast cancer. This suggests that the combination of these drugs is effective for both treating breast cancer and preserving fertility.12345

What safety data is available for the combination of Tamoxifen and Letrozole in breast cancer treatment?

The safety data for Letrozole and Tamoxifen, used individually or in combination, indicates that Letrozole is associated with a higher incidence of bone fractures, osteoporosis, and myocardial infarction, while Tamoxifen has a higher risk of endometrial proliferation, endometrial cancer, and thromboembolic events. Letrozole also required more patients to use lipid-lowering medications compared to Tamoxifen. These findings are based on clinical trials evaluating their use in breast cancer treatment.13467

Is the drug Letrozole, Tamoxifen a promising treatment for fertility preservation in breast cancer?

Yes, Letrozole and Tamoxifen are promising drugs for fertility preservation in breast cancer. They help improve survival rates and reduce the risk of cancer returning, while also supporting fertility preservation.238910

What is the purpose of this trial?

This trial is testing two medication combinations to help women with breast cancer preserve their fertility. It focuses on women with a specific type of breast cancer and aims to find out which combination helps produce more mature eggs. The medications work by managing hormone levels and stimulating the ovaries. Tamoxifen and letrozole have been used to safely manage hormone levels in breast cancer patients undergoing fertility preservation.

Research Team

MR

Mitchell Rosen, M.D.

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults over 18 who have been newly diagnosed with breast cancer and wish to preserve fertility before starting chemotherapy. They must want to undergo ovarian stimulation and egg retrieval.

Inclusion Criteria

New breast cancer diagnosis
Has not yet begun chemotherapy
Desires to undergo ovarian stimulation and oocyte retrieval prior to cancer treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ovarian Stimulation

Participants undergo ovarian stimulation with either letrozole-gonadotropin or tamoxifen-gonadotropin to preserve fertility

Up to 2 weeks
Daily monitoring visits

Oocyte Retrieval

Oocytes are retrieved for cryopreservation after completion of the stimulation cycle

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after oocyte retrieval

4 weeks

Treatment Details

Interventions

  • Letrozole
  • Tamoxifen
Trial Overview The study is testing the effectiveness of two drugs, Tamoxifen and Letrozole, in increasing the number of eggs retrieved for preservation from patients with estrogen-sensitive tumors before they start cancer treatment.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Randomized ER Positive Participants (Tamoxifen)Experimental Treatment1 Intervention
Participants will receive 20 mg of tamoxifen with the first day of non-investigational gonadotropin (tamoxifen-gonadotropin) and stopped on the day of oocyte retrieval
Group II: Randomized ER Positive Participants (Letrozole)Experimental Treatment1 Intervention
Participants will receive 5 mg of letrozole with the first day of non-investigational gonadotropin (letrozole-gonadotropin) and stopped on the day of oocyte retrieval.
Group III: ER Negative (ER-) ParticipantsActive Control1 Intervention
Participants whose disease is ER negative will be consented and used as a reference cohort and will receive no study related medication. The Gonadotropin received is non-investigational and part of usual care.

Letrozole is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Femara for:
  • Breast cancer in postmenopausal women
  • Increasing the chance of ovulation in women with polycystic ovary syndrome
🇪🇺
Approved in European Union as Letrozole for:
  • Early breast cancer in postmenopausal women
  • Advanced breast cancer in postmenopausal women
🇨🇦
Approved in Canada as Letrozole for:
  • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
  • First-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Findings from Research

In a study involving 6182 postmenopausal women with hormone-receptor-positive breast cancer, sequential treatment with tamoxifen and letrozole did not significantly improve disease-free survival compared to letrozole monotherapy, indicating that letrozole alone may be sufficient for treatment.
The updated analysis showed no statistically significant difference in overall survival between letrozole and tamoxifen monotherapy, suggesting that both treatments have similar long-term outcomes, with adverse events consistent with previous reports.
Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer.Mouridsen, H., Giobbie-Hurder, A., Goldhirsch, A., et al.[2022]
Letrozole is highly effective and well-tolerated as a neoadjuvant therapy for postmenopausal women with ER-positive early breast cancer, with 76.8% of patients showing an objective response.
The study suggests that an optimal treatment duration of 4 to 6 months is sufficient to achieve maximum response, with modest benefits observed if treatment is extended beyond this period.
Phase II trial with letrozole to maximum response as primary systemic therapy in postmenopausal patients with ER/PgR[+] operable breast cancer.Llombart-Cussac, A., Guerrero, Á., Galán, A., et al.[2022]
A novel ovarian stimulation protocol using letrozole and tamoxifen for fertility preservation in 40 women with estrogen-positive breast cancer resulted in an average of 11.78 collected oocytes and 9.72 vitrified oocytes, indicating effective oocyte retrieval.
The protocol demonstrated efficiency with a mean stimulation duration of 10.03 days and a mean estradiol level of 623.10, suggesting it is a safe option for women undergoing neoadjuvant chemotherapy.
A specific controlled ovarian stimulation (COS) protocol for fertility preservation in women with breast cancer undergoing neoadjuvant chemotherapy.Cavagna, F., Pontes, A., Cavagna, M., et al.[2022]

References

Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer. [2022]
Phase II trial with letrozole to maximum response as primary systemic therapy in postmenopausal patients with ER/PgR[+] operable breast cancer. [2022]
A specific controlled ovarian stimulation (COS) protocol for fertility preservation in women with breast cancer undergoing neoadjuvant chemotherapy. [2022]
Approval summary: letrozole (Femara® tablets) for adjuvant and extended adjuvant postmenopausal breast cancer treatment: conversion of accelerated to full approval. [2021]
Analyses adjusting for selective crossover show improved overall survival with adjuvant letrozole compared with tamoxifen in the BIG 1-98 study. [2022]
The evolving role of letrozole in the adjuvant setting: first results from the large, phase III, randomized trial BIG 1-98. [2022]
Efficacy of first-line letrozole versus tamoxifen as a function of age in postmenopausal women with advanced breast cancer. [2018]
Efficacy, toxicity, and quality of life in older women with early-stage breast cancer treated with letrozole or placebo after 5 years of tamoxifen: NCIC CTG intergroup trial MA.17. [2022]
Late risk of relapse and mortality among postmenopausal women with estrogen responsive early breast cancer after 5 years of tamoxifen. [2022]
Effects of letrozole or tamoxifen coadministered with a standard stimulation protocol on fertility preservation among breast cancer patients. [2022]
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