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New treatment option for Breast Cancer
Official title BRE-08 Phase II Study of CMC Regimen for Early Stage Breast Cancer
ClinicalTrials.gov ID: NCT06085742
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a non-randomized, single arm phase 2 trial of oral CMC based on conversion of doses that would be delivered with conventional metronomic CMF chemotherapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- I Age ≥ 18 years of age at time of consent
- ECOG performance status 0, 1, or 2
- Histologically confirmed invasive breast cancer documented by biopsy or surgical excision.
- Underwent potentially curative resection of primary breast tumor(s) with no gross residual local-regional disease (patients with microscopically...
- No evidence of distant metastatic disease
You likely can't join if
- people meeting any of the criteria below are ineligible for this study:
- Prior cytotoxic chemotherapy for this breast cancer
- Any investigational agents administered during or within 2 weeks prior to start of CMC chemotherapy
- AJCC stage IIIB-IIIC or stage IV
- Active infection requiring systemic therapy
- Untreated HIV/AIDS
See the full eligibility criteria
Who can join
- I Age ≥ 18 years of age at time of consent
- ECOG performance status 0, 1, or 2
- Histologically confirmed invasive breast cancer documented by biopsy or surgical excision.
- Underwent potentially curative resection of primary breast tumor(s) with no gross residual local-regional disease (patients with microscopically positive margins are eligible if adjuvant radiotherapy is planned), with...
- No evidence of distant metastatic disease
- No prior systemic therapy for this cancer other than pre-operative endocrine therapy
- Treating Oncologist recommends adjuvant chemotherapy without concurrent biologic/targeted therapy. Patients may receive a CDK4/6 inhibitor after completion of all study treatment, concurrently with adjuvant endocrine...
- Tumor is estrogen receptor (ER)-positive (\> 10% by IHC) and/or progesterone receptor (PR)-positive (\> 10% by IHC), HER2-negative by IHC or FISH according to 2018 ASCO-CAP guidelines.
- AJCC pathologic stage: o pT1-3/pN0-2 based on sentinel lymph node biopsy or axillary dissection
- High risk gene expression profile (either luminal B on MammaPrint/BluePrint, or Recurrence Score \> 25 on Oncotype Dx). Study participants are not required to have a high-risk gene expression profile if they have a...
- Involvement of 1-3 axillary lymph nodes with metastatic carcinoma (pN1mic/N1)
- grade 1 tumor \> 3 cm; or grade 2 tumor \> 2 cm; or grade 3 tumors \> 1 cm (size based on pathological assessment of the maximal dimension of the invasive component of the tumor)
- pT1c-T2 and Ki-67 \> 20%
- Presence of lymphovascular invasion stage IIIA (pT3/pN1 or pT1-3/pN2) Age \> 50 and any of the following:
- Primary tumor \> 5 cm (pT3)
- stage IIIA (pT3/pN1 or pT1-3/pN2)
- Adequate organ function as defined in Table 1. All screening labs to be obtained within 30 days prior to registration.
- Patients with synchronous bilateral primary breast tumors or multiple ipsilateral primary breast tumors are eligible if the treating Oncologist determines that the CMC regimen is appropriate therapy for all primary...
- Able to provide written informed consent and HIPAA authorization for release of personal health information.
- Women of childbearing potential must agree to use 2 methods of birth control, at least one being a barrier form of contraception if they are sexually active with a male partner unless they are considered highly unlikely...
- As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
- Patients with history of HIV/AIDS (acquired immunodeficiency syndrome) are eligible for this study if they are receiving anti-retroviral therapy and it does not include any medications known to alter metabolism or side...
- Patients without a history of AIDS-defining opportunistic infections.
- Patients with a history of AIDS-defining opportunistic infections, but they have not had an opportunistic infection within the past 12 months.
- Patients with Hepatitis B (HBV): chronic carriers of HBV infection (HBsAg-positive) or individuals who have serologic evidence of a resolved prior HBV infection (i.e., HBsAg-negative and anti-HBc-positive) are eligible...
- Patients with Hepatitis C (HCV): patients with a history of HCV infection who have completed curative antiviral treatment are eligible if the HCV RNA viral load is below the limit of quantification within 90 days of...
What rules you out
- people meeting any of the criteria below are ineligible for this study:
- Prior cytotoxic chemotherapy for this breast cancer
- Any investigational agents administered during or within 2 weeks prior to start of CMC chemotherapy
- AJCC stage IIIB-IIIC or stage IV
- Active infection requiring systemic therapy
- Untreated HIV/AIDS
- Documented DYPD deficiency
- Pregnant or nursing
- Require anticoagulation with warfarin. Anticoagulation with low molecular weight heparins, heparin, or direct oral anticoagulants (DOACs) is permitted.
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of this investigational regimen, as determined by the treating medical...
- Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
- Other major comorbidity (e.g. advanced cardiopulmonary disease, uncontrolled diabetes mellitus) that may affect the safety or how well it works assessment of this investigational regimen, as determined by study PI
- Inability to swallow pills
- Any medical condition interfering with absorption of oral medications
- Any contraindication for any chemotherapy drug used in the CMC regimen
- Active and ongoing use of medicines known to alter metabolism or side effects of component drugs in CMC.
- Prisoners
- Unable or unwilling to take a large number of oral pills
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.