Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer
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ClinicalTrials.gov Identifier: NCT04768426 |
Recruitment Status :
Recruiting
First Posted : February 24, 2021
Last Update Posted : February 22, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Triple Negative Breast Cancer Breast Cancer | Drug: Capecitabine | Phase 2 |
The Primary Objective is to characterize the circulating tumor DNA (ctDNA) profile of triple-negative breast cancer (TNBC) in participants with residual disease after standard neoadjuvant chemotherapy (NAC) receiving standard-of-care adjuvant capecitabine.
The Secondary Objectives are to correlate ctDNA levels with genomic features and survival.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Circulating Tumor DNA Monitoring During Adjuvant Capecitabine in Patients With Triple-negative Breast Cancer and Residual Disease Following Standard Neoadjuvant Chemotherapy |
Actual Study Start Date : | February 3, 2021 |
Estimated Primary Completion Date : | February 2026 |
Estimated Study Completion Date : | February 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Capecitabine
1000 mg/m2 administered on Days 1 to 14 of 21-day cycles
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Drug: Capecitabine
1000 mg/m2 administered on Days 1 to 14 of 21-day treatment cycles, for 8 cycles.
Other Name: fluoropyrimidine carbamate |
- Baseline levels of ctDNA detection [ Time Frame: 6 months ]
In participants with triple-negative breast cancer (TNBC) who have received standard neoadjuvant chemotherapy (NAC), levels of circulating tumor DNA (ctDNA) will be assessed at baseline and after 6 months of standard adjuvant capecitabine treatment. The outcome will be reported as the number of participants who are:
- ctDNA+ (ctDNA-positive) at baseline and at 6 months.
- ctDNA+ at baseline but ctDNA- (ctDNA-negative) at 6 months.
- ctDNA- at baseline and at 6 months.
- ctDNA- at baseline but ctDNA+ at 6 months.
The outcome is a number without dispersion.
- Correlation of ctDNA levels with genomic features of tumor [ Time Frame: 24 weeks ]
Genomic status of certain mutations in the tumor will be assessed by next-generation sequencing in participants who are:
- ctDNA+ (ctDNA-positive) at baseline and at 6 months.
- ctDNA+ at baseline but ctDNA- (ctDNA-negative) at 6 months.
- ctDNA- at baseline and at 6 months.
- ctDNA- at baseline but ctDNA+ at 6 months.
The genes of interest are:
PIK3CA AKT AKT1 PTEN BRCA1 BRCA2 PALB2 CHEK2 ATM NBN BRIP1 BARD1 MRE11 ATR RAD50 RAD51C RAD51D FANCA FANCC FANCD2 FANCE FANCF FANCG FANCL.
The outcome will be reported as the number of participants with a positive mutation status in the gene of interest. The outcome is a number without dispersion.
- Overall Survival (OS) [ Time Frame: 5 years ]Overall survival (OS) will be assessed as participants remaining alive 5 years from the first treatment initiation. The outcome is reported as the number of participants alive (without dispersion).
- Relapse-Free Survival [ Time Frame: 5 years ]Relapse-free survival is defined as the time from treatment initiation to first invasive relapse or death, through 5 years. The outcome is reported as the number of participants with relapse-free survival (without dispersion) at 5 years.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Anatomic stage I - III triple-negative breast cancer at diagnosis
- Estrogen receptors (ER) and Progesterone receptors (PR) status <10%
- Residual disease following at least 4 cycles of neoadjuvant chemotherapy. Patients who received other investigational immunotherapy or targeted therapy during the neoadjuvant phase of treatment are eligible.
- ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- All clinically significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v 5.0), except alopecia and G2 neuropathy.
- No evidence of metastatic disease.
- A minimum 4-week wash out from previous chemotherapy treatment is required.
- Adequate hematologic function: Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3)
- Adequate hepatic function: Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN. Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN; or calculated creatinine clearance > 50 mL/min using the Cockcroft Gault formula.
- Planned for 6 months or 8 cycles of adjuvant capecitabine.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test.
- WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.
- Male participants and their female partners of child bearing potential must be willing to use an appropriate method of contraception during the study and for 3 months after the last dose.
- Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol
Exclusion Criteria:
- Metastatic breast cancer
- Has not had definitive surgical resection
- Pregnant or breastfeeding
- Has not completed definitive adjuvant radiation if planned
- Known human immunodeficiency virus (HIV) positivity or active hepatitis B or C.
- Investigational agents within 4 weeks of study initiation
- Inability to swallow oral medications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04768426
Contact: Cindy Garcia | 650-497-1681 | cinmaig@stanford.edu |
United States, California | |
Stanford University | Recruiting |
Stanford, California, United States, 94304 | |
Contact: Cindy Garcia 650-497-1681 cmaigarcia@stanford.edu | |
Principal Investigator: Melinda Telli, MD |
Principal Investigator: | Melinda Telli | Stanford Universiy |
Responsible Party: | Stanford University |
ClinicalTrials.gov Identifier: | NCT04768426 |
Other Study ID Numbers: |
IRB-57723 BRS0121 ( Other Identifier: OnCore ) |
First Posted: | February 24, 2021 Key Record Dates |
Last Update Posted: | February 22, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
TNBC Triple Negative Breast Cancer Post neoadjuvant Residual disease Capecitabine |
Breast Neoplasms Triple Negative Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Capecitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |