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Closed (no longer recruiting)Last updated: 30 January 2024

CO40151: This phase I trial is evaluating the safety and effectiveness of an oral drug (Ipatasertib) given in combination with an immunotherapy drug (Atezolizumab) and a chemotherapy drug (either paclitaxel or nab-paclitaxel) in patients with locally advanced or metastatic triple negative breast cancer who have had no prior chemotherapy in the advanced settingA Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Clinical summary

Summary

This is a non-randomised clinical trial, in which participants will be assigned to one of two treatment arms. All participants will receive an oral dose of ipatasertib once daily on days 1-21 of each 28 day cycle, and atezolizumab intravenously on days 1 and 15 of each 28 day cycle. Depending on their assignment, participants will also receive either paclitaxel or nab-paclitaxel by intravenous infusion on Days 1, 8 and 15 of each 28 day cycle.

Conditions

This trial is treating patients with triple negative breast cancer.

Cancer

Breast Cancers Breast

Age

People18+

Phase

I

Trial Acronym

CO40151

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche

Scientific Title

A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Eligibility

Inclusion

General:

  • Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  • Adequate hematologic and organ function.
  • For Cohorts 1, 2 and 4: Life expectancy of at least 6 months.
  • For men and women of child bearing potential: agreement to remain abstinent or use protocol defined contraceptive measures during the treatment period and for at least 28 days after the last dose of ipatasertib, 6 months after the last dose of paclitaxel, nab-paclitaxel, or doxorubicin, and 12 months after the last dose of cyclophosphamide, and 5 months after the last dose of atezolizumab, whichever occurs later along with refraining from donating sperm or eggs during this same period.

Disease-specific:

  • For Cohorts 1, 2 and 4: histologically documented TNBC that is locally advanced or metastatic and is not amenable to resection with curative intent.
  • For Cohort 2: disease progression following one or two lines of systemic therapy for inoperable locally advanced or metastatic TNBC.
  • For Cohorts 1, 2 and 4: measurable disease according to RECIST v1.1 criteria.
  • For Cohort 2: Treated brain or spinal cord metastases are allowed if participants have stable disease and are not on steroid treatment.
  • For Cohort 3: histologically documented TNBC with a primary breast tumour size of > 2 cm by at least one radiographic or clinical measurement and disease stage at presentation of cT2-4 cN0-3 cM0.
  • For Cohort 3: participant agreement to undergo appropriate surgical management, including axillary lymph node surgery and partial or total mastectomy, after completion of neoadjuvant treatment.
  • For Cohort 4: participants must have centrally confirmed PD-L1-positive tumour.

Exclusion

General:

  • History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
  • Active infection requiring antibiotics.
  • History of or current evidence of HIV infection.
  • Known clinically significant history of liver disease.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure (other than anticipated breast surgery for Cohort 3) during the course of the study.
  • Pregnant or breastfeeding.
  • New York Heart Association (NYHA) Class II, III, or IV heart failure; left ventricular ejection fraction < 50%; or active ventricular arrhythmia requiring medication.
  • Treatment with approved or investigational cancer therapy within 14 days prior to Day 1 of Cycle 1.
  • Prior treatment with an Akt inhibitor.

Disease-specific:

  • For Cohorts 1 and 4: history of or known presence of brain or spinal cord metastases.
  • For Cohorts 1 and 4: participants who have received previous systemic therapy for inoperable locally advanced or metastatic TNBC, including chemotherapy, immune checkpoint inhibitors, or targeted agents.
  • Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy.
  • Participants who have received palliative radiation treatment to peripheral sites (e.g., bone metastases) for pain control and whose last treatment was completed 14 days prior to Day 1 of Cycle 1 and have recovered from all acute, reversible effects.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites.
  • Uncontrolled tumor related complications.
  • Uncontrolled hypercalcaemia or symptomatic hypercalcaemia requiring continued use of bisphosphonate therapy.
  • Malignancies other than breast cancer within 5 years prior to Day 1 of Cycle 1.
  • For Cohort 3, participants with the following are excluded: [1] prior history of invasive breast cancer; [2] prior systemic therapy for treatment and/or prevention of invasive breast cancer; [3] previous therapy with anthracyclines or taxanes for any malignancy; [4] bilateral breast cancer; [5] undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes; [6] undergone axillary lymph node dissection (ALND) prior to initiation of neoadjuvant therapy; [6] history of other malignancy within 5 years prior to screening; [7] history of cerebrovascular accident within 12 months prior to initiation of study treatment; [8] cardiopulmonary dysfunction; [9] known allergy or hypersensitivity to the components of cyclophosphamide/doxorubicin formulations and filgrastim or pegfilgrastim formulations; [10] severe infection within 4 weeks prior to initiation of study treatment; [11] treatment with therapeutic oral or IV (Intravenous) antibiotics within 2 weeks prior to initiation of study treatment and [12] prior treatment with CD137 agonists or immune checkpoint - blockade therapies.

Ipatasertib-specific:

  • History of Type I or Type II diabetes mellitus requiring insulin.
  • Grade >= 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia.
  • History of or active inflammatory bowel disease or active bowel inflammation.
  • Clinically significant lung disease.
  • Treatment with strong CYP3A inhibitors or strong CYP3A inducers.

Atezolizumab-specific:

  • Active or history of autoimmune disease or immune deficiency.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
  • Prior allogeneic stem cell or solid organ transplantation.
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with atezolizumab or within 5 months after the last dose of atezolizumab.
  • History of hypersensitivity reactions to study drug or any component of the study drug formulation.
  • Treatment with systemic immunostimulatory agents and immunosuppressive medication treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study.

Paclitaxel-specific:

- Grade >= 2 peripheral neuropathy.

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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