Capecitabine for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Novant Health Cancer Institute, Winston-Salem, NC
Breast Cancer+3 More
Capecitabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether there are differences in the effectiveness of surgery for patients with TNBC based on the presence of ctDNA.

See full description

Eligible Conditions

  • Breast Cancer
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Cancer

Study Objectives

This trial is evaluating whether Capecitabine will improve 1 primary outcome and 7 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 1 year.

1 year
1 year Disease Free Survival (DFS)
Frequency and Severity of Adverse Events
2 year
2 year Disease Free Survival (DFS) ARM 1
2 years
2 year Disease Free Survival (DFS) in ARM 2
2 year Disease Free Survival (DFS) in ARM 3
Overall Disease Free Survival (DFS)
Overall Distant Disease Free Survival (DDFS)
5 years
5 year Overall Survival (OS)

Trial Safety

Safety Progress

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

Other trials for Breast Cancer

Trial Design

3 Treatment Groups

Arm 3
1 of 3
Arm 2
1 of 3
Arm 1
1 of 3
Active Control
Experimental Treatment

This trial requires 197 total participants across 3 different treatment groups

This trial involves 3 different treatments. Capecitabine 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 1Arm 1a: Patients who are ctDNA-positive and harbor a genomic target. DNA repair pathway = talazoparib + capecitabine (CLOSED) Arm 1b: Patients who are ctDNA-positive and harbor a genomic target. Immunotherapy pathway = atezolizumab + capecitabine Arm 1c: Patients who are ctDNA-positive and harbor a genomic target. PI3K Pathway = inavolisib + capecitabine ---> atezolizumab Arm 1d: Patients who are ctDNA-positive and harbor a genomic target. DNA Repair + Immunotherapy = talazoparib + atezolizumab + capecitabine
Arm 3
Other
Arm 3 subjects have plasma ctDNA negative. Treatment of patient and physician's choice will be given with strong consideration for capecitabine. Dose, schedule and duration of treatment to be determined by treating physician.
Arm 2
Other
Arm 2 subjects have plasma ctDNA positive but do not have a genomically driven treatment option. Treatment of physician's choice will be given with strong consideration for capecitabine. Dose, schedule and duration of treatment to be determined by treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Talazoparib
FDA approved
Capecitabine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years for reporting.

Closest Location

Novant Health Cancer Institute - Winston-Salem, NC

Eligibility Criteria

This trial is for patients born any sex 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:
General Inclusion Criteria
Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or may be obtained separately.
Age ≥ 18 years at the time of consent.
ECOG Performance Status 0 or 1 within 21 days prior to study registration.
Must have clinical stage I-III at diagnosis (AJCC 8th edition) based on initial evaluation by physical examination and/or breast imaging prior to neoadjuvant chemotherapy.
Must have completed preoperative (neoadjuvant) chemotherapy for this index case. NOTE: Acceptable preoperative regimens include an anthracycline or a taxane, or both. Participants who received preoperative therapy as part of a clinical trial may enroll. Participants may not have received adjuvant chemotherapy after surgery prior to registration. Bisphosphonate use is allowed.
Residual invasive disease in the breast measuring at least 1 cm. The presence of DCIS without invasion does not qualify as residual disease in the breast.
The primary tumor must be palpable or macroscopically detectable. show original
You have residual cancer burden score 2 or 3. show original
You have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer per pathology report. show original

Patient Q&A Section

What are the signs of triple negative breast neoplasms?

"These tumors are often difficult to separate from invasive carcinomas and metastatic breast tumors, and for this reason, an awareness of the signs and symptoms of triple negative breast carcinomas is imperative for timely diagnosis." - Anonymous Online Contributor

Unverified Answer

What is triple negative breast neoplasms?

"The luminal subtype prevails in TNBC patients and in women with ER-negative tumors; in younger patients; and a worse metastatic behavior was observed. In TNBC, histological grade, HER2 positivity, or EGFR positivity (but not TNBC subtype) significantly impacted OS." - Anonymous Online Contributor

Unverified Answer

How many people get triple negative breast neoplasms a year in the United States?

"The number of triple negative breast neoplasms diagnosed annually has been decreasing in the last 10 years. This decline is likely due to improved screening in the United States, increased recognition of these neoplasms, and improved survival from their detection. The total number of new cases diagnosed annually is approximately 11,857, or 1.7% of new breast cancers." - Anonymous Online Contributor

Unverified Answer

What are common treatments for triple negative breast neoplasms?

"Clinically relevant information regarding the most common [treatment options for triple negative breast neoplasms] is crucial to [allow clinicians to make informed decisions as to the best treatment strategy for this subtype of breast cancer] and our study [is one in a series of related articles that discusses treatment options for specific breast cancer subtypes], which could help patients to [avoid erroneous treatment decisions]. Additionally, our study will be useful for [clinicians] who wish to identify effective treatments for triple negative breast neoplasms, potentially improving their knowledge of existing treatments and enhancing clinical decision making." - Anonymous Online Contributor

Unverified Answer

What causes triple negative breast neoplasms?

"The cause of triple negative breast neoplasms is not known. Given the poor prognostic profile of patients with triple negative breast cancer, the need for further research to ascertain the underlying cause of these neoplasms is paramount." - Anonymous Online Contributor

Unverified Answer

Can triple negative breast neoplasms be cured?

"There are two main methods in current study to test for triple negative breast neoplasms: (1) The new triple negative breast cancer markers may exist and (2) The new gene-chip is developed to make it possible if a mutation exists in this new triple negative breast cancer marker, and/or the existing new triple negative breast neoplasm markers, so that it is possible to distinguish triple positive and triple negative for treatment plan, and so the triple negative breast cancer is cured easily and safely." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating triple negative breast neoplasms?

"In the past, surgery, radiation, and chemotherapy were used to treat TNBCs. However, research to find treatments with a higher success rate has been ongoing. A recent study reported that [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) cells with the FUS-CHOP or MYC+ ALK inactivation can be efficiently killed by treating them with alveolar rhabdomyosarcoma protein 1 (ARRMS1) cDNA (1kb/2kb) in vitro, which causes tumor cell death through disrupting a cell-cycle arrest. Therefore, ARRMS1 cDNA should be useful to induce cell death in TNBC-treated cancers." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in capecitabine for therapeutic use?

"Capecitabine was shown to be an effective alternative in TNBC with favorable response to chemotherapy. Results from a recent clinical trial has demonstrated that metastatic TNBC patients with more than one line of chemotherapy, older age>66 years, and triple-negative subtype should be considered for therapeutic use of capecitabine." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing triple negative breast neoplasms?

"The prevalence of triple negative breast neoplasms was 18% (n=37). A statistically significant difference in incidence was seen between patient and tumor characteristics. For patients, the incidence was higher for younger age, high BMI, ER negativity, and the presence of HER-2 amplification in primary breast tumors (p<0.05). For tumors, the incidence was higher for younger age, absence of estrogen receptors, and high HER-2 expression (p<0.05). For patients, HER-2, which is positively related to triple negative phenotype, was also a predictor of triple negative phenotype (OR 1.9; 95% CI:1.5-3.2; p=0.004)." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for triple negative breast neoplasms?

"[All women with triple negative breast cancer should consider clinical trials. However, there are certain subgroups of patients who have higher risk of developing the disease, and therefore have a higher likelihood of benefiting from clinical trials and receiving the best treatment options. Clinically trial-eligible patients can be identified by using several validated risk prediction models, such as the triple negative breast cancer clinical trials prediction model ((TRIMP-TNBC)." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving capecitabine?

"Only the aforementioned trial has been a placebo free arm compare to other chemotherapeutic regimines (e.g. cisplatin/gemcitabine/taxanes and doxorubicin/cyclophosphamide/methotrexate/trastuzumab). The use of capecitabine should be investigated as a placebelly approach to breast cancer in the clinic setting." - Anonymous Online Contributor

Unverified Answer

How quickly does triple negative breast neoplasms spread?

"There is no conclusive evidence that TNBCs either spread more slowly than other [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s or spread more rapidly than other breast cancers. For any patient, the possibility of finding new cancer should be added to the list of reasons to evaluate patients with new breast cancer. In many patients, more than one cancer is involved, and an appropriate therapeutic planning should be determined after the initial diagnosis, based on patient history, mammogram results, tumor size, TNM staging, the extent of surgical treatment, and the presence or absence of distant metastases." - 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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