Monitoring for Prognostic Stage IIA Breast Cancer AJCC v8

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
European Institute of Oncology, Milano, Italy
Prognostic Stage IIA Breast Cancer AJCC v8+17 More
Monitoring - Other
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of fasting and metformin can reduce the risk of breast cancer.

See full description

Eligible Conditions

  • Prognostic Stage IIA Breast Cancer AJCC v8
  • Anatomic Stage IIB Breast Cancer AJCC v8
  • Prognostic Stage IIB Breast Cancer AJCC v8
  • Anatomic Stage 1 Breast Cancer AJCC v8
  • Anatomic Stage IA Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage IB Breast Cancer AJCC v8
  • Anatomic Stage IIA Breast Cancer AJCC v8
  • Invasive Breast Carcinoma
  • Breast Ductal Carcinoma In Situ
  • Prognostic Stage 2 Breast Cancer AJCC v8
  • Prognostic Stage 1 Breast Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Prognostic Stage IIA Breast Cancer AJCC v8

Study Objectives

This trial is evaluating whether Monitoring will improve 5 primary outcomes and 11 secondary outcomes in patients with Prognostic Stage IIA Breast Cancer AJCC v8. Measurement will happen over the course of Baseline up to 4-6 weeks.

Week 6
Change in circulating biomarkers
Change in pre-post treatment Ki67 labeling index in invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) (in the absence of IBC)
Change of CIP2A-PP2A-GSK3beta-MCL-1 axis in cancer tissue
Change of Ki67 in cancer tissue
Change of Ki67 labeling index in cancer tissue as a surrogate biomarker of clinical response between arms.
Post-treatment
Difference in adjacent DCIS (in the presence of IBC), if present, or intraepithelial neoplasia Ki67
Difference of M30
Difference of phosphorylated S6
Post-treatment (4-6 weeks)
Difference in post-treatment adjacent DCIS (in the presence of IBC), if present, or intraepithelial neoplasia Ki67 between arms
Up to 4-6 weeks
Alcohol consumption
Difference of the area under the curve of glucose levels
Eating habits
Frequency of occurrence of dose limiting toxicity
Incidence of adverse events
Physiological distress
Tobacco

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Prognostic Stage IIA Breast Cancer AJCC v8

Trial Design

2 Treatment Groups

Arm II (glucose monitoring)
1 of 2
Arm I (fasting, glucose monitoring, counseling, metformin)
1 of 2
Active Control
Experimental Treatment

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Monitoring is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm I (fasting, glucose monitoring, counseling, metformin)Patients fast for >= 16 hours every night and use the continuous glucose monitoring system for 4-6 weeks. Patients also receive nutritional counseling sessions on days 0 and 10. Beginning week 2, patients also receive metformin hydrochloride extended release PO QD until the day of surgery. Treatment continues for 4-6 weeks (until surgery) in the absence of disease progression or unacceptable toxicity. Patients undergo the collection of blood samples at baseline and at the final study visit (days 28-43), and the collection of tissue at the time of surgery (days 28-43).
Arm II (glucose monitoring)Patients continue their usual dietary pattern and use the continuous glucose monitoring system for 4-6 weeks (until surgery). Patients undergo the collection of blood samples at baseline and at the final study visit (days 28-43), and the collection of tissue at the time of surgery (days 28-43).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~430

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4-6 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 4-6 weeks for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Creatinine within normal institutional limits
Women with histologically confirmed luminal (ER+ve and/or progesterone [PgR]+ve >= 1%) operable IBC (cT1-2, cN0-1, Mx) candidate to elective surgery and not to neo-adjuvant treatment. Women with larger tumors who refuse neo-adjuvant chemotherapy before surgery can also be eligible. Luminal HER2+ve (cT1, cN0) IBC and DCIS are also eligible
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status is equal to or less than 1 (Karnofsky is greater than or equal to 70%). show original
White blood cells are above 3000/microliter. show original
A person's absolute neutrophil count is 1,500 or higher per microliter of blood. show original
Platelets >= 100,000/microliter
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional upper limit of normal
Creatinine clearance estimated with Cockcroft-Gault formula > 45 mL/min
Female participants of child-bearing potential must agree to use contraception such as barrier method of birth control or abstinence, prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she has to inform her study physician immediately. The effects of metformin hydrochloride extended release on the developing human fetus at the recommended therapeutic dose are unknown

Patient Q&A Section

What is the survival rate for carcinoma, mammary ductal?

"The overall five-year survival rate for patients diagnosed with carcinoma, mammary ductal was 59% (95% CI, 47-68%). Survival varied depending on stage of disease, but the five-year survival rate was significantly higher for patients diagnosed with stage I or II disease compared with patients diagnosed with stage III or IV disease (P<0.001). Patients treated with lumpectomy had a better prognosis than those treated with mastectomy(P<0.05). Age at diagnosis of breast cancer did not impact survival, regardless of surgical technique." - Anonymous Online Contributor

Unverified Answer

Is monitoring typically used in combination with any other treatments?

"The degree of adherence to treatment guidelines was low; however, the use of more intensive monitoring increased significantly when patients were diagnosed with breast cancer at younger ages, had higher incomes, and more education." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma, mammary ductal?

""Experts" have pointed out that the cohorts that participate in clinical research are selected on the basis of their willingness and ability to make informed decisions about cancer treatments; therefore, there is no reason why they would not be willing or able to participate in a study of a new therapy for breast cancer. For patients with advanced breast cancer, however, participation in a randomized controlled study may be more like a gamble than a rational decision. It is important to remember that medical advances occur when people who are willing to take part in studies update themselves by participating in the clinical trials examining new therapies." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets carcinoma, mammary ductal?

"It's important to remember that the average age someone gets [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is 37 years old. Please see the article "Breast Cancer" in the Breast Cancer section below." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving monitoring?

"Comparison of our results to those of previous randomized controlled studies suggests that we have made progress in identifying new biomarkers. There are still gaps in our knowledge about molecular pathways involved in carcinogenesis. We propose that this avenue of research will continue to be pursued as part of an ongoing effort to identify safe therapeutic targets to treat breast cancer. It is important to note that no adjuvant therapy has been proven to be superior to standard chemotherapy alone in improving survival rates. Further work on this topic will undoubtedly lead to improved treatment strategies." - Anonymous Online Contributor

Unverified Answer

Does carcinoma, mammary ductal run in families?

"Results from a recent clinical trial suggest that breast cancer susceptibility genes are not solely inherited as a Mendelian trait, but rather, are influenced by environmental factors." - Anonymous Online Contributor

Unverified Answer

Is monitoring safe for people?

"Results from a recent clinical trial provides an estimate of incidence and mortality rates over a 5-year period following CT scan examination of the chest in men who have had previous screening examinations. It was found that post-CT scan surveillance should be implemented with caution, particularly if previous CT scans were performed on the same day as the initial CT scan." - Anonymous Online Contributor

Unverified Answer

Has monitoring proven to be more effective than a placebo?

"This meta-analysis concluded that, as reviewed by other authors, "no evidence exists that cancer screening has any effect on mortality when compared with a placebo" (Sundstrom et al., 1997; Stensrud et al., 2003). The authors questioned whether the results were affected by publication bias because unpublished data were excluded from the meta-analysis. They suggested that further research was needed to confirm their findings. [The average mortality rate for women who have had a mammogram is 2.4% per year.] Thus, a 5-year screening program would probably detect about 1 new case annually out of every 200,000 women. The health care costs of yearly screening for 10 years would total about $1 billion." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, mammary ductal spread?

"The time to local recurrence after mastectomy was 8 months longer when the cancer had metastatic disease compared with those without. It would be prudent to perform routine IHC on all mastectomies to identify early local recurrence and to treat promptly." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating carcinoma, mammary ductal?

"Advances have happened in recent years in the field of carcinoma, but there is still much work to be done. In order to develop a new drug into the clinic, more research needs to be conducted on this disease." - Anonymous Online Contributor

Unverified Answer

What does monitoring usually treat?

"A few studies have suggested that routine use of regular breast self-examination may reduce mortality from breast cancer in women at high risk. Since adequate screening is not always available, most women already receive regular mammogram examinations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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