Hormone Therapy for Breast Cancer

(TEXT Trial)

No longer recruiting at 239 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: International Breast Cancer Study Group

Must be taking: Triptorelin, Exemestane, Tamoxifen

Must not be taking: Hormonal therapy, Chemotherapy

Disqualifiers: Pregnancy, Noncompliance, Other malignancy, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two hormone therapy combinations to determine which better treats hormone-responsive breast cancer in premenopausal women. It compares triptorelin with exemestane against triptorelin with tamoxifen to block estrogen, which can promote cancer growth. Women who have had their breast cancer completely removed, with no signs of it spreading beyond the breast and nearby lymph nodes, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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

The trial requires that you do not take any concurrent hormonal therapies, including oral or transdermal hormonal therapy, estrogen, progesterone, androgens, or hormonal contraceptives. If you are on any of these, you will need to stop them to participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of exemestane and triptorelin is generally well-tolerated. In one study, 95.9% of patients remained alive after five years, indicating that serious side effects are rare. Another study found that this combination prevented breast cancer recurrence in 92.8% of patients over five years.

Research also supports the safety of tamoxifen and triptorelin. Tamoxifen has been widely used and is known to lower the risk of breast cancer. When combined with triptorelin, it is usually safe and effective for women who have not yet gone through menopause.

Both treatments have been tested on many patients, providing strong evidence of their safety. While side effects can occur, they are usually manageable and not severe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the hormone therapy involving Exemestane and Tamoxifen for breast cancer because these treatments work in tandem with ovarian function suppression to potentially improve outcomes. Exemestane, part of the aromatase inhibitor class, blocks the production of estrogen, which fuels certain breast cancers. Tamoxifen, on the other hand, is a selective estrogen receptor modulator (SERM) that prevents estrogen from binding to its receptor. The unique combination of these therapies with ovarian function suppression, either through medication, surgery, or radiation, offers a comprehensive approach to managing hormone-sensitive breast cancer, especially in premenopausal women. This combination aims to enhance the effectiveness of current treatments by more thoroughly reducing estrogen levels in the body, potentially leading to better long-term outcomes for patients.

What evidence suggests that this trial's treatments could be effective for hormone-responsive breast cancer?

In this trial, participants will receive either exemestane with ovarian function suppression (OFS) or tamoxifen with OFS. Research has shown that exemestane with OFS can be highly effective, with studies finding that about 85.9% of patients remain disease-free with this combination. Exemestane also reduces the risk of breast cancer recurrence or death by 24% compared to tamoxifen. Tamoxifen, meanwhile, is effective as well; it can reduce breast density by 20%, which is linked to a lower risk of developing breast cancer. Both treatments block estrogen, helping to slow or stop the growth of breast cancer cells. ^{3 5 6 7 8}

Who Is on the Research Team?

Barbara Walley, MD, FRCPC

Principal Investigator

Tom Baker Cancer Centre

Olivia Pagani, MD

Principal Investigator

Oncology Institute of Southern Switzerland

Are You a Good Fit for This Trial?

This trial is for premenopausal women with hormone-responsive breast cancer that's been surgically removed and isn't widespread. Participants must not be pregnant, should use nonhormonal birth control, and have no history of other cancers or serious diseases in the last 5 years. They can't be on hormonal treatments or have had prior chemotherapy for breast cancer.

Inclusion Criteria

I haven't had any cancer except certain skin cancers or non-spreading breast cancer in the last 5 years.

My estrogen levels are considered premenopausal after surgery.

My breast cancer diagnosis was confirmed through tissue examination.

Exclusion Criteria

No history of noncompliance to medical regimens

I don't have any chronic diseases that would interfere with long-term treatment.

I haven't had any cancer except for skin cancer in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ovarian function suppression by triptorelin and either exemestane or tamoxifen for 5 years

5 years

Monthly visits for injections

Follow-up

Participants are monitored for disease-free survival and overall survival

5 years

Every 3 months for 1 year, every 6 months for 5 years, then annually

Quality of Life Assessment

Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Exemestane
• Tamoxifen
• Triptorelin

Trial Overview

The study compares two hormone-blocking treatments: triptorelin with exemestane versus triptorelin with tamoxifen. It aims to find out which combination is more effective at preventing the growth of breast cancer cells by blocking estrogen.

How Is the Trial Designed?

Group I: E+OFS Experimental Treatment 2 Interventions

Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.

Group II: T+OFS Active Control 2 Interventions

Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.

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

Approved in European Union as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Approved in United States as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Approved in Canada as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Approved in Japan as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Who Is Running the Clinical Trial?

International Breast Cancer Study Group

Lead Sponsor

Trials

29

Recruited

25,100+

ETOP IBCSG Partners Foundation

Lead Sponsor

Trials

66

Recruited

58,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Breast International Group

Collaborator

Trials

34

Recruited

53,600+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2697518/

A review of the use of exemestane in early breast cancer

A relative reduction in risk of breast cancer recurrence or death of 24% has been shown with exemestane compared with tamoxifen when given after 2 to 3 years of ...

2.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1803164

Tailoring Adjuvant Endocrine Therapy for Premenopausal ...

Among the patients who were assigned to receive exemestane plus ovarian suppression, the rate of disease-free survival was 85.9%, a difference ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00066703

Study Details | NCT00066703 | Triptorelin With Either ...

Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving ...

4.

esmoopen.com

esmoopen.com/article/S2059-7029(24)01855-6/fulltext

Ten-year update of HOBOE phase III trial comparing ...

In this updated analysis, L plus triptorelin, with or without Z, demonstrated a statistically significant DFS improvement over T plus ...

5.

nature.com

nature.com/articles/s41523-024-00680-0

Estrogen levels in young women with hormone receptor ...

Endocrine effects of adjuvant letrozole+ triptorelin compared with tamoxifen+ triptorelin in premenopausal patients with early breast cancer.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4455847/

Clinical utility of exemestane in the treatment of breast cancer

The 5-year OS rates were high in both groups: 95.9% in the exemestane plus OFS group and 96.9% in the tamoxifen plus OFS group (HR for death in the exemestane– ...

7.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1404037

Adjuvant Exemestane with Ovarian Suppression in ...

The rate of freedom from breast cancer at 5 years was 92.8% in the exemestane–ovarian suppression group, as compared with 88.8% in the tamoxifen ...

8.

ascopubs.org

ascopubs.org/doi/10.1200/jco.2004.22.90140.2041

Estrogen suppression of 8-week treatment with ...

Conclusions: Greater estrogen suppression was observed in premenopausal subjects on T plus EX versus T plus P. The increase in pharmacological effectiveness ...