BridgeMD
New treatment option for Breast Cancer Female
Official title The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06439693
What this study is testing
What is Nab-Paclitaxel?
Nab-Paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer female.
Also referred to as Abraxane, ABI-007.
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
- The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants.
- Phase 2: a mid-size study of how well it works
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
- Participants must have histologically or cytologically confirmed unresectable locally advanced or metastatic invasive breast carcinoma. Patients must...
- Diagnosis of HER2-positive invasive breast carcinoma and 3+ by immunohistochemistry on both breast and metastatic biopsies, as defined by the current...
- No prior systemic therapy for invasive breast cancer, aside from first-line trastuzumab/pertuzumab/taxane (THP) within 6 weeks from treatment start...
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of trastuzumab, pertuzumab, paclitaxel, trastuzumab...
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
You likely can't join if
- Prior history of invasive breast carcinoma
- Treatment with any other investigational agents for this condition.
- Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 28 days of study entry or an anticipated...
- Extracranial palliative radiotherapy within 7 days prior to enrollment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to trastuzumab, pertuzumab, paclitaxel, trastuzumab...
- Participants with a medical history of myocardial infarction within 6 months before enrollment or symptomatic CHF (NYHA Class II to IV).
See the full eligibility criteria
Who can join
- Participants must have histologically or cytologically confirmed unresectable locally advanced or metastatic invasive breast carcinoma. Patients must have stage IV breast carcinoma at diagnosis (i.e., de novo...
- Diagnosis of HER2-positive invasive breast carcinoma and 3+ by immunohistochemistry on both breast and metastatic biopsies, as defined by the current American Society of Clinical Oncology - College of American...
- No prior systemic therapy for invasive breast cancer, aside from first-line trastuzumab/pertuzumab/taxane (THP) within 6 weeks from treatment start. Prior endocrine therapy for non-invasive breast carcinoma or...
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of trastuzumab, pertuzumab, paclitaxel, trastuzumab deruxtecan, T-DM1 and tucatinib in Participants \<18 years of age, children...
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
- Left ventricular ejection fraction (LVEF) ≥50%, as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) documented within 12 weeks prior to first dose of study treatment, or within 12 weeks before...
- Participants must meet the following organ and marrow function as defined below within 28 days prior to registration:
- Hgb ≥9.0 g/dL
- Absolute Neutrophil Count ≥ 1,000 /mm3
- Platelets ≥100,000/mm3
- Total bilirubin ≤ 1.5 x ULN (institutional) or direct bilirubin within normal limits in patients with a history of Gilbert\'s syndrome.
- AST and ALT ≤ 2.5 x ULN (institutional) or ≤ 5 x ULN for participants with documented liver metastases
- Serum creatinine ≤ 1.5 x ULN (institutional) OR calculated GFR ≥60mL/min
- Participants with concurrent human immunodeficiency virus (HIV) infection are eligible provided the following criteria are met:
- CD4+ T-cell (CD4+) counts \> 350 cells/uL
- No history of AIDS-defining opportunistic infection within 12 months prior to enrollments
- Any medication used in an ART regimen must have no known interaction with the agents used in the study treatment regimen.
- Participants with active or chronic Hepatitis B or C are eligible provided they meet the liver function criteria described in 3.1.7 and are not on a medication with a known liver function criteria described in 3.1.7 and...
- patients with chronic HBV infection with active disease who meet the FDA criteria for anti-HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy.
- patients with a history of HCV infection should have completed curative antiviral treatment. HCV viral load must be below the limit of quantification.
- patients who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible.
- Participants with brain metastases identified at diagnosis or at time of screening are eligible if the following criteria are met:
- Known, untreated brain metastases must undergo definitive local therapy - as determined by treating physician - prior to study entry.
- Treated brain metastases must be clinically stable since treatment. Restaging brain MRI is not required to deem eligibility if local therapy was given within 28 days from first dose of study treatment. Patients are...
- 7 days for stereotactic radiosurgery (SRS);
- 14 days for whole-brain radiation therapy (WBRT);
- 28 days for surgical resection.
- Patients who have already started THP prior to study entry and have brain metastasis detected at screening MRI are eligible after completion of definitive local therapy- as determined by treating physician. Systemic...
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- This study involves agents that have known genotoxic, mutagenic and teratogenic effects. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of...
- Women of childbearing potential must have had a negative pregnancy test within 14 days of registration. Childbearing potential is defined as: those who have not been surgically sterilized and/or have had a menstrual...
- Ability to understand and the willingness to sign a written informed consent document indicating awareness of the investigational nature and the risks of this study
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
What rules you out
- Prior history of invasive breast carcinoma
- Treatment with any other investigational agents for this condition.
- Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 28 days of study entry or an anticipated need for major surgery during the study.
- Extracranial palliative radiotherapy within 7 days prior to enrollment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to trastuzumab, pertuzumab, paclitaxel, trastuzumab deruxtecan, trastuzumab emtansine, tucatinib.
- Participants with a medical history of myocardial infarction within 6 months before enrollment or symptomatic CHF (NYHA Class II to IV).
- people must not have any of the following:
- Any untreated brain lesion on screening MRI, unless approved by the Sponsor Investigator
- Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \>2 mg of dexamethasone (or equivalent).
- Known or concurrent leptomeningeal disease on screening MRI
- Poorly controlled (\>1/week) generalized or complex partial seizures
- History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial...
- History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- History of other lung disease, such as:
- Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of study enrolment, severe asthma, severe chronic...
- Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening.
- Prior pneumonectomy.
- Active or uncontrolled clinically serious infection
- Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications
- Have ongoing ≥ Grade 2 diarrhea of any etiology
- Participants receiving any medications or substances that are inhibitors or inducers of CYP2C8 and/or CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly...
- Pregnant women are excluded from this study because of potential for teratogenic or abortifacient effects of study drugs. Because there is an unknown but potential risk for adverse events in nursing infants secondary to...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, 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 Boston, Massachusetts, 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.