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Antibody-Drug Conjugate

TMZ for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Alexandra S Zimmer, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated at the beginning of every cycle while on study, for an average of 9.6 months (range 2.8-33.9 months).
Awards & highlights

Study Summary

This trial is studying the combination of two drugs as a possible treatment for breast cancer that has spread to the brain.

Eligible Conditions
  • Breast Cancer
  • Brain Cancer
  • Brain Metastases

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated at the beginning of every cycle while on study, for an average of 9.6 months (range 2.8-33.9 months).
This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated at the beginning of every cycle while on study, for an average of 9.6 months (range 2.8-33.9 months). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Maximum Tolerated Dose (MTD) of Temozolomide (TMZ) When Used With T-DM1 (Ado-trastuzumab)
Phase II: Median Amount of Time Participant Survives Without New Brain Lesions After Starting Treatment
Secondary outcome measures
Phase I: Median Survival
Phase I: Number of Participants With Dose Limiting Toxicity (DLTs) at Each Dose Level
Phase I: Number of Participants With Grade 3 and/or Grade 4 Adverse Events
+3 more
Other outcome measures
Phase I: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Side effects data

From 2021 Phase 1 & 2 trial • 116 Patients • NCT03150862
73%
Nausea
73%
Fatigue
45%
Headache
35%
Constipation
35%
Decreased appetite
35%
Alopecia
33%
Anaemia
33%
Vomiting
30%
Diarrhoea
28%
Dizziness
25%
Dysgeusia
23%
Weight decreased
20%
Hemiparesis
18%
Platelet count decreased
15%
Aphasia
15%
Urinary incontinence
15%
Seizure
15%
Anxiety
15%
Insomnia
15%
Neutrophil count decreased
15%
White blood cell count decreased
15%
Memory impairment
13%
Fall
13%
Abdominal pain
10%
Dry mouth
10%
Cough
10%
Agitation
10%
Blood creatinine increased
10%
Hyponatraemia
10%
Oedema peripheral
10%
Thrombocytopenia
10%
Confusional state
8%
Tinnitus
8%
Nasal congestion
8%
Vision blurred
8%
Aspartate aminotransferase increased
8%
Alanine aminotransferase increased
8%
Lymphocyte count decreased
8%
Pulmonary embolism
8%
Malaise
8%
Hypophosphataemia
8%
Back pain
8%
Visual field defect
5%
Lymphopenia
5%
Skin atrophy
5%
Ear pain
5%
Hypoacusis
5%
Flatulence
5%
Cognitive disorder
5%
Hypoaesthesia
5%
Haematuria
5%
Neutropenia
5%
Abdominal distension
5%
Dyspepsia
5%
Asthenia
5%
Gait disturbance
5%
Otitis media
5%
Upper respiratory tract infection
5%
Contusion
5%
Radiation skin injury
5%
Hyperglycaemia
5%
Hypokalaemia
5%
Partial seizures
5%
Irritability
5%
Dermatitis acneiform
5%
Stomatitis
3%
Hydrocephalus
3%
Hypertension
3%
Cerebral cyst
3%
Suicide attempt
3%
Chest pain
3%
Dehydration
3%
Sinus congestion
3%
Dyspnoea
3%
Eructation
3%
Nephrolithiasis
3%
Hiccups
3%
Pyrexia
3%
Hemiplegia
3%
Bronchitis
3%
Wound infection
3%
Brain oedema
3%
Dysarthria
3%
Nervous system disorder
3%
Ear discomfort
3%
Mental status changes
3%
Dry eye
3%
Oral candidiasis
3%
Oral herpes
3%
Non-cardiac chest pain
3%
Radiation injury
3%
Blood bilirubin increased
3%
Night sweats
3%
Muscle spasms
3%
Disturbance in attention
3%
Depression
3%
Postoperative wound infection
3%
Sepsis
3%
Apraxia
3%
Psychogenic seizure
3%
Vasogenic cerebral oedema
3%
Dysphagia
3%
Sinusitis
3%
Urinary tract infection
3%
Hypernatraemia
3%
Hypoalbuminaemia
3%
Arthralgia
3%
Groin pain
3%
Muscular weakness
3%
Myalgia
3%
Pain in extremity
3%
Hypersomnia
3%
Paraesthesia
3%
Tremor
3%
Pollakiuria
3%
Rhinitis allergic
3%
Dermatitis
3%
Dermatitis contact
3%
Pruritus
3%
Rash maculo-papular
3%
Deep vein thrombosis
3%
Neck pain
3%
Syncope
3%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Dose Expansion (E) - Pamiparib 6 Wks + RT 6 Wks
Arm B: DE-Pamiparib 6 Wks + RT 6 Wks + Temozolomide
Arm C: E- Pamiparib + Temozolomide 60 mg
Arm A: DE-Pamiparib 4 Wks + RT 6 Wks
Arm A: DE- Pamiparib 6Wks + RT 6 Wks
Arm C: DE - Pamiparib + Temozolomide 20 mg
Arm C: DE - Pamiparib + Temozolomide 40 mg
Arm 1Arm A: DE - Pamiparib 2 Wks + Radiation Therapy (RT) 6 Wks

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: 2B/Phase II /Arm B, Ado-trastuzumab (T-DMI) + Temozolomide (TMZ)Experimental Treatment2 Interventions
T-DM1 + TMZ at recommended phase 2 dose (RP2D)
Group II: 1/Phase I: Ado-trastuzumab (T-DMI) + Temozolomide (TMZ) Dose EscalationExperimental Treatment2 Interventions
T-DM1 + TMZ in dose escalation
Group III: 2A /Phase II: Arm A, Ado-trastuzumab (T-DMI) AloneActive Control1 Intervention
T-DM1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
T-DM1
2014
Completed Phase 2
~450
TMZ
2007
Completed Phase 3
~1530

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,260 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,348 Patients Enrolled for Breast Cancer
Alexandra S Zimmer, M.D.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
30 Total Patients Enrolled
Stanley Lipkowitz, M.D.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you tell me how many individuals are enrolled in this experiment?

"Unfortunately, this trial is no longer admitting patients. The study began on April 18th, 2018 and ended recruitment on November 11th, 2022. However, there are still many other trials underway that may be of interest. For example, 3561 clinical trials for breast cancer and 43 for TMZ are actively enrolling participants."

Answered by AI

Are there any spots left in this clinical trial for new patients?

"Unfortunately, this specific clinical trial is no longer recruiting patients. However, there are 3604 other trials that are still taking applications. This particular study was first posted on April 18th, 2018 and had its last edit on November 11th, 2022."

Answered by AI

What is the point of this research?

"The key metric that this experiment will use to judge success is the median amount of time patients survive without disease progression. This will be tracked over a 21 day period. Additionally, secondary outcomes like time to whole brain irradiation and adverse event frequency will also be monitored."

Answered by AI

What are the unique aspects of this research?

"Since its initial investigation in 2008, the anti-cancer effects of TMZ have been explored in 43 different clinical trials. These investigations took place across 1456 cities and 57 countries."

Answered by AI

Does this research stand alone or build upon other similar investigations?

"As of right now, there are 43 different clinical trials studying the efficacy of temozolomide. Out of those 43 medical studies, 9 are in Phase 3. The majority of research teams looking into this treatment option are based in Brewer, Maine; though, there are 6088 locations running trials for TMZ globally."

Answered by AI
Recent research and studies
The Lancet OncologyJournal
Pertuzumab, Trastuzumab, and Docetaxel for Her2-positive Metastatic Breast Cancer (CLEOPATRA Study): Overall Survival Results from a Randomised, Double-blind, Placebo-controlled, Phase 3 Study
Swain, Sandra M, Sung-Bae Kim, Javier Cortés, Jungsil Ro, Vladimir Semiglazov, Mario Campone, Eva Ciruelos, et al.. 2013. “Pertuzumab, Trastuzumab, and Docetaxel for Her2-positive Metastatic Breast Cancer (CLEOPATRA Study): Overall Survival Results from a Randomised, Double-blind, Placebo-controlled, Phase 3 Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(13)70130-x.
Clinical & Experimental MetastasisJournal
Activity of T-DM1 in Her2-positive Breast Cancer Brain Metastases
Bartsch, Rupert, Anna S. Berghoff, Ursula Vogl, Margaretha Rudas, Elisabeth Bergen, Peter Dubsky, Karin Dieckmann, et al.. 2015. “Activity of T-DM1 in Her2-positive Breast Cancer Brain Metastases”. Clinical & Experimental Metastasis. Springer Science and Business Media LLC. doi:10.1007/s10585-015-9740-3.
Journal of Clinical OncologyJournal
Lapatinib or Trastuzumab Plus Taxane Therapy for Human Epidermal Growth Factor Receptor 2–positive Advanced Breast Cancer: Final Results of NCIC CTG MA.31
Gelmon, Karen A., Frances M. Boyle, Bella Kaufman, David G. Huntsman, Alexey Manikhas, Angelo Di Leo, Miguel Martin, et al.. 2015. “Lapatinib or Trastuzumab Plus Taxane Therapy for Human Epidermal Growth Factor Receptor 2–positive Advanced Breast Cancer: Final Results of NCIC CTG MA.31”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2014.56.9590.
Future OncologyJournal
Temozolomide in Secondary Prevention of Her2-positive Breast Cancer Brain Metastases
Zimmer, Alexandra S, Seth M Steinberg, Dee Dee Smart, Mark R Gilbert, Terri S Armstrong, Eric Burton, Nicole Houston, et al.. 2020. “Temozolomide in Secondary Prevention of Her2-positive Breast Cancer Brain Metastases”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2020-0094.
~2 spots leftby Apr 2025
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