Swiss Group for Clinical Cancer Research
About 10-20% of all individuals with breast cancer have a so-called triple-negative tumor (TNBC). This type of breast cancer has a particularly unfavorable course and a higher mortality rate compared to other forms of breast cancer. Research studies show that it is important for individuals with TNBC to achieve a so-called pathologic complete response (pCR) to treatment. In the phase II study SAKK 66/22, it is being investigated whether the administration of the drug INT230-6 before surgery for breast cancer can increase the rate of pCR in the tumor and affected lymph nodes. The tolerability of INT230-6 as well as other factors such as response to treatment and the possibility of breast-conserving surgery are also being examined.
Triple-negative Breast Cancer
TNBC - Triple-Negative Breast Cancer
INT230-6
neoadjuvant immuno-chemotherapy
Phase 2
Triple-negative breast cancer (TNBC) poses significant challenges due to its aggressiveness, high relapse rates, and increased mortality. The Keynote-522 study revealed a 19.6% incidence of event-free survival (EFS) events in early-stage TNBC patients over 39 months. Achieving pathological complete response (pCR) and clearing positive lymph nodes are crucial prognostic factors. The IMP INT230-6 is a combination of the chemotherapeutic agents cisplatin and vinblastine, along with a molecule that facilitates their distribution in tumor tissue. INT230-6, currently in clinical trials, has demonstrated the ability to induce up to 95% necrosis in T2 breast cancer tumors and it has been observed to stimulate systemic immune activation during the period between diagnosis and surgery. Moreover, promising results have been seen in seven refractory breast cancer patients, resulting in decreased Ki67 levels and a median overall survival of 12 months. Completed and ongoing U.S. clinical trials including 91 patient a window-of-opportunity trial demonstrate the safety and early activity of INT230-6, both alone and with checkpoint inhibitors like pembrolizumab and ipilimumab, particularly in resistant cases. Based on the positive outcomes, it will be assessed within this clinical trial the safety and early clinical activity of INT230-6 in early TNBC patients, addressing the high unmet medical need in this challenging subtype.
Study Type : | Interventional |
Estimated Enrollment : | 54 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early Triple-negative Breast Cancer (TNBC). An Open-label Randomized Two-cohort Phase 2 Clinical Trial. INVINCIBLE-4-SAKK |
Actual Study Start Date : | June 30, 2024 |
Estimated Primary Completion Date : | March 2026 |
Estimated Study Completion Date : | December 2029 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort A experimental Intervention 1-2 weeks: - 2 Injections of INT230-6 into primary tumor of the breast Thereafter Standard of Care including surgery (30 weeks) Immuno-chemotherapy -> 24 weeks Neoadjuvant therapy as Keynote-522 (Standard of Care) - 24 Weeks Pembrolizumab q3W in combination with Cycles 1-4: Paclitaxel q1W + Carboplating q1W or q3W Cycle 5-8: Doxorubicin or Epirubicin q3W + Cyclophospahmide q3W MRI Surgery |
Drug: INT230-6 |
Other: Cohort B Standard of Care Intervention 1-2 weeks: - No intervention - start of immune-chemotherapy after randomization Thereafter Standard of Care including surgery (30 weeks) Immuno-chemotherapy -> 24 weeks Neoadjuvant therapy as Keynote-522 (Standard of Care) - 24 Weeks Pembrolizumab q3W in combination with Cycles 1-4: Paclitaxel q1W + Carboplating q1W or q3W Cycle 5-8: Doxorubicin or Epirubicin q3W + Cyclophospahmide q3W MRI Surgery |
Other: neoadjuvant immuno-chemotherapy |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Tumor Center Aarau
Aarau, Switzerland, 5000
Not yet recruiting
St. Claraspital
Basel, Switzerland, 4058
Not yet recruiting
Oncology Institute of Italian Switzerland (IOSI)
Bellinzona, Switzerland, 6500
Not yet recruiting
Graubünden Cantonal Hospital
Put, Switzerland, 7000
Not yet recruiting
Baselland Cantonal Hospital
Liestal, Switzerland, 4410
Not yet recruiting
St. Gallen Cantonal Hospital
St. Gallen, Switzerland, 9007
Not yet recruiting
TBZO - Tumor and Breast Center Eastern Switzerland
St. Gallen, Switzerland, 9016
Not yet recruiting
Winterthur Cantonal Hospital
Winterthur, Switzerland, 8401
Not yet recruiting
University Hospital Zurich - Clinic for Gynecology
Zürich, Switzerland, 8091