Symptom Monitoring for Young Women on Hormone Therapy for Breast Cancer

Not currently recruiting at 500 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Southwest Oncology Group

Must be taking: Oral endocrine therapy

Must not be taking: Oral estrogen, Progesterone

Disqualifiers: Metastatic cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 72 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how active symptom monitoring might help young women with stage I-III breast cancer adhere to their hormone therapy treatment. Hormone therapy can cause side effects that lead some women to stop treatment early. The trial will compare two groups: one will receive regular education materials and weekly symptom check-ins, while the other will only receive education materials. It is designed for women who have had breast cancer surgery and are either already on or about to start hormone therapy, and who have not had metastatic breast cancer. Participants need to be comfortable using a smartphone, tablet, or computer to report symptoms or able to answer questions via phone.

As an unphased trial, this study offers a unique opportunity to contribute to understanding how symptom monitoring can improve treatment adherence.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you must not take oral estrogen or progesterone treatments during the study. You should continue your hormone therapy for breast cancer as part of the trial.

What prior data suggests that this symptom monitoring method is safe for young women on hormone therapy for breast cancer?

Research shows that hormone therapy is usually effective but can have some side effects. One study found that taking tamoxifen for five years lowered the risk of breast cancer returning by 40% and reduced the chance of dying by 30%. However, using hormone therapy for too long might not provide extra benefits and could increase the risk of bone fractures.

Another study indicated that hormone therapy does not raise the risk of death when used with topical estrogen, a hormone treatment applied to the skin. While hormone therapy helps reduce cancer risk, it's important to be aware of possible side effects like bone problems.

Overall, hormone therapy is well-researched and has been used for a long time, though it may cause side effects that need management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to enhance hormone therapy for young women with breast cancer. Unlike typical hormone treatments that focus solely on managing the cancer, this trial adds a layer of personalized symptom monitoring. Patients in one arm of the study receive regular health education and weekly check-ins about their symptoms via text, email, or phone, helping to manage side effects more effectively. This approach aims to improve the overall quality of life and adherence to treatment by addressing symptoms promptly.

What evidence suggests that active symptom monitoring and patient education could be effective for young women on hormone therapy for breast cancer?

Research has shown that hormone therapy can reduce the risk of breast cancer recurrence by blocking hormones like estrogen, which some breast cancers need to grow. However, this treatment may cause side effects, such as hot flashes and joint pain. In this trial, participants in one arm will receive hormone therapy along with regular symptom assessments. Studies suggest that addressing side effects sooner might help participants continue their hormone therapy. This ongoing check-in could make it easier for women to adhere to their medication. ^{6 7 8 9 10}

Who Is on the Research Team?

Norah L Henry

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for young women aged 18 or older with Stage I-III hormone receptor positive breast cancer. They must have completed chemotherapy, surgery, and started or plan to start standard oral endocrine therapy. Participants need to be pre- or peri-menopausal at diagnosis and able to complete surveys in English or Spanish. Exclusions include current treatment for non-breast malignancies, prior aromatase inhibitor therapy, metastatic cancer, use of estrogen/progesterone treatments during the study, pregnancy plans within 80 weeks of study participation.

Inclusion Criteria

I had breast cancer surgery at least 14 days ago.

If you are a woman, you were still having regular menstrual periods or had hormone levels consistent with premenopausal status before or shortly after being diagnosed with breast cancer.

Participants must be offered the opportunity to participate in specimen banking for translational medicine. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system

Exclusion Criteria

I have never taken tamoxifen for breast cancer before.

I am not currently being treated for cancer outside of my breast.

I have not previously taken aromatase inhibitors for breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive endocrine therapy (ET) and standard of care clinic visits with a cancer provider at specified intervals. In Arm I, participants also undergo active symptom monitoring.

72 weeks

Clinic visits at 12, 24, 36, 48, 60, and 72 weeks; phone visit at 80 weeks

Symptom Monitoring

In Arm I, participants are asked 6 brief questions about symptoms weekly by email, text, or phone call for the first 6 months, then every 4 weeks for 12 months.

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including optional blood specimen collection.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Hormone Therapy

Trial Overview The ASPEN Study is testing whether active symptom monitoring plus patient education helps young women continue their hormone therapy compared to patient education alone. The intervention includes a web-based symptom assessment tool and educational material about managing side effects from hormone therapy medicines.

How Is the Trial Designed?

Group I: ARM I (ET, health education, symptom assessment) Experimental Treatment 6 Interventions

Patients receive ET and standard of care clinic visits with a cancer provider at 12, 24, 36, 48, 60, and 72 weeks, and phone visit at 80 weeks to access ongoing use ET medication. Patients are asked 6 brief questions about symptoms weekly by email, text, or phone call for the first 6 months, then every 4 weeks for 12 months. Patients also receive a list of websites with information about breast cancer, side effects of breast cancer medicines, and ways to help with heart health. Patients have the option to submit blood specimen collection at baseline, 3, 12, and 18 months.

Group II: ARM II (ET, health education) Active Control 5 Interventions

Patients receive ET and standard of care clinic visits with a cancer provider at 12, 24, 36, 48, 60, and 72 weeks, and phone visit at 80 weeks to access ongoing use ET medication. Patients also receive a list of websites with information about breast cancer, side effects of breast cancer medicines, and ways to help with heart health. Patients have the option to submit blood specimen collection at 3, 12, and 18 months.

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

Approved in European Union as Hormone Therapy for:

• Breast cancer
• Hormone receptor-positive breast cancer

Approved in United States as Hormone Therapy for:

• Breast cancer
• Hormone receptor-positive breast cancer
• Stage I-III breast cancer

Approved in Canada as Hormone Therapy for:

• Breast cancer
• Hormone receptor-positive breast cancer

Approved in Japan as Hormone Therapy for:

• Breast cancer
• Hormone receptor-positive breast cancer

Approved in Switzerland as Hormone Therapy for:

• Breast cancer
• Hormone receptor-positive breast cancer

Who Is Running the Clinical Trial?

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Letrozole, a third-generation aromatase inhibitor, has emerged as a significant advancement in hormonal therapy for postmenopausal women with hormone-sensitive early breast cancer, showing improved efficacy compared to the traditional treatment with Tamoxifen.

Recent trials indicate that letrozole offers distinct pharmacokinetic and pharmacodynamic advantages, along with a different side effect profile, which may enhance treatment outcomes for patients compared to other hormonal agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Letrozole: present and future role in the treatment of breast cancer. Amar, S., Roy, V., Perez, EA.[2019]

In a study of 3887 post-menopausal patients with hormone receptor-positive early breast cancer, over 85% persisted with letrozole treatment for 12 months, but 14.6% discontinued, primarily due to side effects.

Musculoskeletal symptoms and sleep disorders were the most significant adverse events leading to treatment discontinuation, with hazard ratios of 2.55 and 1.95, respectively, indicating a strong need for targeted compliance programs to support patients experiencing these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of side-effects on early therapy persistence with letrozole in post-menopausal patients with early breast cancer: Results of the prospective EvAluate-TM study. Nabieva, N., Fehm, T., Häberle, L., et al.[2022]

Recent trials indicate that third-generation aromatase inhibitors (AIs) like anastrozole and letrozole are at least as effective, and possibly more effective, than tamoxifen for treating metastatic breast cancer, with improved response rates and time to progression.

In a study of 1021 patients, anastrozole showed a slightly better overall response rate (29% vs. 26%) and significantly improved time to progression (8.5 months vs. 7.0 months) compared to tamoxifen, while letrozole demonstrated even greater improvements in response rate (30% vs. 20%) and clinical benefit (49% vs. 38%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of tamoxifen and aromatase inhibitors/inactivators in postmenopausal patients. Pritchard, KI.[2013]

Letrozole, a type 2 aromatase inhibitor, effectively reduces estrogen levels in postmenopausal women, leading to improved disease-free survival in breast cancer patients compared to other treatments like tamoxifen.

The drug is generally well-tolerated, though it may cause side effects such as hot flushes, joint pain, and a potential increased risk of fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Letrozole: advancing hormone therapy in breast cancer. Lee, RJ., Armstrong, AC., Wardley, AM.[2018]

Aromatase inhibitors (AIs) like anastrozole, letrozole, and exemestane are effective adjuvant therapies for postmenopausal women with hormone receptor-positive invasive breast cancer, showing similar overall survival rates compared to tamoxifen.

While AIs have acceptable toxicity profiles with fewer endometrial cancers and thromboembolic events, they are associated with a higher risk of bone fractures and joint pain compared to tamoxifen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant endocrine therapy in hormone receptor-positive postmenopausal breast cancer: evolution of NCCN, ASCO, and St Gallen recommendations. Carlson, RW., Hudis, CA., Pritchard, KI.[2019]

In a study of 686 postmenopausal women with early breast cancer, both anastrozole and exemestane showed comparable treatment-related symptoms (TRS) and health-related quality of life (HRQL) over 5 years, indicating similar tolerability between the two aromatase inhibitors.

However, a significant burden of TRS was linked to poorer HRQL, and women who experienced more side effects before starting treatment were more likely to discontinue therapy early, highlighting the importance of managing side effects to improve treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported predictors of early treatment discontinuation: treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG) MA.27 (E1Z03). Wagner, LI., Zhao, F., Goss, PE., et al.[2023]

In a network assessment of third-generation aromatase inhibitors (AIs) for postmenopausal estrogen receptor-positive breast cancer, letrozole was associated with the highest risk of severe cardiovascular (CV) events, followed by exemestane and anastrozole.

None of the AIs demonstrated a lower risk of cardiovascular events compared to tamoxifen, except for a lower incidence of thromboembolism, suggesting that while AIs are effective treatments, they may carry significant cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study on individual aromatase inhibitors on cardiovascular safety profile: a network meta-analysis. Zhao, X., Liu, L., Li, K., et al.[2020]

Tamoxifen is the standard treatment for postmenopausal women with hormone-sensitive early breast cancer, but it has side effects that have led researchers to look for safer alternatives.

Third-generation aromatase inhibitors like anastrozole, letrozole, and exemestane have shown better efficacy and a more favorable side effect profile compared to tamoxifen in randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant aromatase inhibitor therapy for early breast cancer: A review of the most recent data. Grana, G.[2018]

Letrozole, a nonsteroidal aromatase inhibitor, has been found to be superior to tamoxifen in treating metastatic breast cancer, indicating its potential to replace tamoxifen in various treatment scenarios.

The review highlights the need for further clinical studies to compare the risks and benefits of letrozole and tamoxifen for new indications, particularly in adjuvant therapy for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Letrozole in the treatment of breast cancer. Shaw, HS., Ellis, MJ.[2019]

Third-generation aromatase inhibitors, such as letrozole, anastrozole, and exemestane, are effective and well-tolerated treatments for postmenopausal women with hormone-sensitive metastatic or locally advanced breast cancer.

These inhibitors are not only beneficial as first or second-line treatments but also serve as valuable options in neoadjuvant therapy and for localized tumors in women who cannot undergo surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary hormone treatment in postmenopausal women with breast cancer. Maciá Escalante, S., Pons Sanz, V., Rodríguez Lescure, A., et al.[2019]

Letrozole, a third-generation aromatase inhibitor, effectively lowers estrogen levels in postmenopausal women and has been shown to be more effective than tamoxifen in treating hormone-receptor-positive early breast cancer.

Clinical trials indicate that letrozole significantly improves disease-free survival, particularly in high-risk patients, making it a crucial option in adjuvant therapy for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on the use of letrozole in breast cancer. Wu, M., Goss, PE.[2019]

Letrozole, an aromatase inhibitor, has been shown to be significantly more effective than tamoxifen in treating advanced breast cancer, particularly in terms of median time to progression and response rates, while being well tolerated by patients.

Anastrozole and exemestane also provide effective alternatives to tamoxifen, with anastrozole showing equivalent efficacy overall but superior results in hormone receptor-positive patients, and exemestane demonstrating better response rates, although overall survival data is still pending.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aromatase inhibitors in advanced breast cancer. Mouridsen, HT.[2019]

Third-generation aromatase inhibitors (AIs) like anastrozole, exemestane, and letrozole have shown superior efficacy compared to tamoxifen in treating hormone-receptor-positive breast cancer in postmenopausal women, particularly in neoadjuvant and adjuvant settings.

Letrozole, when used as extended adjuvant therapy after 5 years of tamoxifen, significantly improved disease-free survival and overall survival in node-positive patients, highlighting its effectiveness in long-term treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The breast cancer continuum in hormone-receptor-positive breast cancer in postmenopausal women: evolving management options focusing on aromatase inhibitors. Rugo, HS.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39395534

Protocol for the SWOG S2010 randomized controlled efficacy ... The ASM intervention includes 6 symptom questions (hot flashes, sadness, anxiety, insomnia, vaginal dryness, joint pain) that will be completed via text, email ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820436

Remote Monitoring App for Endocrine Therapy Adherence ... In this randomized clinical trial of 304 women, a remote monitoring app combined with text messages did not improve AET adherence in the first year.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2347562523001890

Symptom experience in endocrine therapy for breast ... ET can effectively reduce the recurrence rate of breast cancer, but also lead to a series of symptoms in patients, including hot flashes, cognitive decline, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05568472

Study Details | NCT05568472 | Monitoring Symptoms to ... This phase III trial compares the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III ...

5. cancer.org cancer.org/cancer/types/breast-cancer/treatment/hormone-therapy-for-breast-cancer.html

Hormone Therapy for Breast Cancer Some breast cancers grow in response to hormones like estrogen. Hormone therapy blocks these hormones, which keeps the cancer from growing.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10453164/

Extended Adjuvant Endocrine Therapy in Early Breast ... Taking tamoxifen for 5 years has been shown to reduce the risk of breast cancer recurrence by 40% and mortality by 30% compared to patients ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2104162

Duration of Adjuvant Aromatase-Inhibitor Therapy in ... Extending hormone therapy by 5 years provided no benefit over a 2-year extension but was associated with a greater risk of bone fracture.

8. nih.gov nih.gov/news-events/news-releases/breast-cancer-risk-younger-women-may-be-influenced-hormone-therapy

Breast cancer risk in younger women may be influenced by ... Women who used E-HT had a 14% reduction in breast cancer incidence compared to those who never used hormone therapy. Notably, this protective ...

9. esmoopen.com esmoopen.com/article/S2059-7029(25)00926-3/fulltext

Extended adjuvant endocrine therapy in early breast cancer 10 years of adjuvant ET is superior to 5 years in reducing recurrences. Seven to eight years of ET improves outcomes compared with 5 years.

10. sciencedirect.com sciencedirect.com/science/article/pii/S0305737225000027

Safety of topical estrogen therapy during adjuvant ... The present study suggests that TE exposure of breast cancer survivors on TAM or AI did not appear to increase mortality risk. Concurrent use of TAM and TE did ...