Breast Cancer FemalePhase 1NCT03518242

Molecular Profile of Breast Cancer in Ugandan Patients With Stage IIB-III Breast Cancer

A Phase 1 study testing Cyclophosphamide, Methotrexate and Capecitabine in people with Breast Cancer Female and Anatomic Stage IIB Breast Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 2 sites in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This phase I trial studies the molecular profile of breast cancer in Ugandan patients with stage IIB-III breast cancer. Creating a molecular profile of breast cancer my help doctors learn more about biological factors associated with breast cancer in Ugandan patients with as well as measure the benefits of locally… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer Female, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
What is being tested?: Cyclophosphamide, Methotrexate and Capecitabine
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 2 sitesUganda
Study dates: 6 Jun 2018to 4 May 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women with any menopausal status, with newly diagnosed, locally advanced and histologically confirmed invasive breast cancer (Patients with stage 2B [i.e. T3N0], 3A, 3B, and 3C disease)
Absolute neutrophil count (ANC) > 1500/mm
Hemoglobin > 9 g/dL
Platelets >=100,000 cells/mm^3
Total bilirubin =< 1.2 mg/dL
International normalized ratio (INR) =< 1.5 x upper limit of normal (ULN)

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Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x ULN
Serum alkaline phosphatase should be 1.5 x ULN
Patients with positive hepatitis B or C serologies without known active disease must meet the eligibility requirements for ALT, AST, total bilirubin, INR, activated partial thromboplastin time (aPTT), and alkaline phosphatase on at least two consecutive occasions, separated by at least 1 week
Adequate renal function with serum creatinine < 1.5 x ULN
Premenopausal patients must have a negative serum or urine pregnancy test, including women who have had a tubal ligation and for women less than 12 months after the onset of menopause
Women of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment
Left ventricular ejection fraction >= 50%
Eastern Cooperative Oncology Group (ECOG) performance status < 2
Signed written informed consent

Who cannot join

A treatment-free interval of < 6 months with previous chemotherapy
Active, unresolved infection or systemic disease (e.g. pulmonary or metabolic disease)
Patients with active liver disease
Patients with active cardiac disease, including congestive heart failure (or therapy specifically for congestive heart failure [CHF])
Patients with uncontrolled hypertension (diastolic >100 mmHg or systolic > 160 mmHg)
Known hypersensitivity to any of the drugs

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Significant current illness (including psychiatric illness)
Any social situations or other conditions that in the opinion of the investigator limit compliance with study requirements
Calcium imbalance
Patients that have received treatment with sorividine or brividine (herpex) or any related analogue within 4 weeks prior to starting the investigational product (IP)
Eye problems
Patients on any of the following medications: acitretin, azathioprine, Bacillus Calmette Guerin (BCG) (intravesicular), belimumab, deferiprone, diphyrone, etanercept, foscarnet, gimeracil, levetriracetam, natalizumab, pimercrolimus, retinoids, sulfazalazine, tacrolimus tofacitininb
Patients receiving any anticoagulation (including warfarin)

Trial locations and contacts

2 sites in 1 country.

Uganda2 sites

New Mulago Hospital
Kampala, 256
Uganda Cancer Institute
Kampala, 3935

Other trials in Uganda

About this study

Official title: Defining the Molecular Profile of Breast Cancer in Uganda and Its Clinical Implications

Read the detailed description

OUTLINE:

SPECIMEN COLLECTION: Patients undergo collection of tumor tissue and peripheral blood samples for analysis via next generation sequencing to identify novel pathways in the pathogenesis of breast cancer.

TREATMENT: Patients are invited to participate in a treatment study. Patients receive cyclophosphamide orally (PO) daily on days 1-21, methotrexate PO QD on days 1, 8, and 15, and capecitabine PO twice daily (BID) on days 1-14. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study, patients are followed up for 24 months.

Conditions: Breast Cancer Female, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8
Being tested: Cyclophosphamide, Methotrexate, Capecitabine, Biospecimen Collection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CyclophosphamideDrug
Also called Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate
Given PO
MethotrexateDrug
Also called Abitrexate, Brimexate, Emtexate, Fauldexato
Given PO
CapecitabineDrug
Also called Xeloda
Given PO
Biospecimen CollectionProcedure or surgery
Undergo biospecimen collection

Study groups in NCT03518242
Study group	Role	What they receive
Treatment (Specimen collection, chemotherapy)	Experimental	SPECIMEN COLLECTION: Patients undergo collection of tumor tissue and peripheral blood samples for analysis via next generation sequencing to identify novel pathways in the pathogenesis of breast cancer. TREATMENT: Patients are invited to participate in a treatment study. Patients receive cyclophosphamide PO daily on days 1-21, methotrexate PO QD on days 1, 8, and 15, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Receives: Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Capecitabine; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

Distribution of molecular subtypes
Will classify Ugandan women into four categories based on molecular subtypes: estrogen receptor (ER) negative (-)/progesterone receptor (PR) - /HER2 - (triple negative), ER-/PR-/HER positive (+) (HER2), ER+/PR+/HER2- (luminal A), and ER/PR+/HER2 + (luminal B) and compare to aggregate data from previously published data on a cohort of African-American women using chi square tests.
Measured: Up to 9 months
Sensitivity to polymerase chain reaction (PCR)
Sensitivity, defined as the proportion of women with a particular receptor detected by PCR, among those women who had the receptor detected by immunohistochemistry (IHC), to polymerase chain reaction (PCR) will be estimated with 95% confidence intervals (CIs), using IHC as the gold standard. Will also calculate the percent agreement between PCR and IHC, and compute the kappa statistic with 95% CIs to assess receptor status agreement between reverse transcription (RT)-PCR and IHC.
Measured: Up to 9 months
Specificity of PCR
Specificity, defined as the proportion of women with a receptor not detected by PCR, among women who did not have the receptor detected by IHC, to PCR will be estimated with 95% CIs, using IHC as the gold standard. Will also calculate the percent agreement between PCR and IHC, and compute the kappa statistic with 95% CIs to assess receptor status agreement between RT-PCR and IHC.
Measured: Up to 9 months
Patient adherence to treatment
Patient adherence as the proportion of women completing 8 cycles of therapy compared to historical controls from the UCI cancer registry database using chi square tests
Measured: Up to 168 days (8 cycles)
Incidence of adverse events
Will describe the extent of adverse events assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Will also compare patient adherence and adverse events using chi square tests and compare survival using log-rank tests.
Measured: Up to 6 months
Overall Survival
Will use Kaplan-Meier methodology.
Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 20184 May 2022

First posted8 May 2018
Study start6 Jun 2018
Primary completion4 May 2022
Study completion4 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03518242
Sponsor's protocol ID: U025
Other IDs: NCI-2018-02609, RG1001403, 8424
Status last verified: Jun 2022
First submitted: 25 Apr 2018
Last updated: 8 Jun 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Defining the Molecular Profile of Breast Cancer in Uganda and Its Clinical Implications
ClinicalTrials.gov ID: NCT03518242
Acronym / sponsor ID: U025
Conditions: Breast Cancer Female, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Fred Hutchinson Cancer CenterUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: 6 Jun 2018 (actual)
Primary completion: 4 May 2022 (actual)
Study completion: 4 May 2022 (actual)
First posted: 8 May 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OUTLINE:

After completion of study, patients are followed up for 24 months.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (Specimen collection, chemotherapy)	Experimental	Drug: Cyclophosphamide, Drug: Methotrexate, Drug: Capecitabine, Procedure: Biospecimen CollectionSPECIMEN COLLECTION: Patients undergo collection of tumor tissue and peripheral blood samples for analysis via next generation sequencing to identify novel pathways in the pathogenesis of breast cancer. TREATMENT: Patients are invited to participate in a treatment study. Patients receive cyclophosphamide PO daily on days 1-21, methotrexate PO QD on days 1, 8, and 15, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Women with any menopausal status, with newly diagnosed, locally advanced and histologically confirmed invasive breast cancer (Patients with stage 2B [i.e. T3N0], 3A, 3B, and 3C disease)
Absolute neutrophil count (ANC) > 1500/mm
Hemoglobin > 9 g/dL
Platelets >=100,000 cells/mm^3
Total bilirubin =< 1.2 mg/dL

Key exclusion criteria (13 listed)

A treatment-free interval of < 6 months with previous chemotherapy
Active, unresolved infection or systemic disease (e.g. pulmonary or metabolic disease)
Patients with active liver disease
Patients with active cardiac disease, including congestive heart failure (or therapy specifically for congestive heart failure [CHF])
Patients with uncontrolled hypertension (diastolic >100 mmHg or systolic > 160 mmHg)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CyclophosphamideAlso: Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrateGiven PO	Drug	Treatment (Specimen collection, chemotherapy)
MethotrexateAlso: Abitrexate, Brimexate, Emtexate, FauldexatoGiven PO	Drug	Treatment (Specimen collection, chemotherapy)
CapecitabineAlso: XelodaGiven PO	Drug	Treatment (Specimen collection, chemotherapy)
Biospecimen CollectionUndergo biospecimen collection	Procedure or surgery	Treatment (Specimen collection, chemotherapy)

Primary outcome

Distribution of molecular subtypes
Time frame: Up to 9 months
Will classify Ugandan women into four categories based on molecular subtypes: estrogen receptor (ER) negative (-)/progesterone receptor (PR) - /HER2 - (triple negative), ER-/PR-/HER positive (+) (HER2), ER+/PR+/HER2- (luminal A), and ER/PR+/HER2 + (luminal B) and compare to aggregate data from previously published data on a cohort of African-American women using chi square tests.
Sensitivity to polymerase chain reaction (PCR)
Time frame: Up to 9 months
Sensitivity, defined as the proportion of women with a particular receptor detected by PCR, among those women who had the receptor detected by immunohistochemistry (IHC), to polymerase chain reaction (PCR) will be estimated with 95% confidence intervals (CIs), using IHC as the gold standard. Will also calculate the percent agreement between PCR and IHC, and compute the kappa statistic with 95% CIs to assess receptor status agreement between reverse transcription (RT)-PCR and IHC.
Specificity of PCR
Time frame: Up to 9 months
Specificity, defined as the proportion of women with a receptor not detected by PCR, among women who did not have the receptor detected by IHC, to PCR will be estimated with 95% CIs, using IHC as the gold standard. Will also calculate the percent agreement between PCR and IHC, and compute the kappa statistic with 95% CIs to assess receptor status agreement between RT-PCR and IHC.
Patient adherence to treatment
Time frame: Up to 168 days (8 cycles)
Patient adherence as the proportion of women completing 8 cycles of therapy compared to historical controls from the UCI cancer registry database using chi square tests
Incidence of adverse events
Time frame: Up to 6 months
Will describe the extent of adverse events assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Will also compare patient adherence and adverse events using chi square tests and compare survival using log-rank tests.
Overall Survival
Time frame: Up to 1 year
Will use Kaplan-Meier methodology.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Manoj Menon principal investigator

Fred Hutchinson Cancer Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distribution of molecular subtypes (time frame: Up to 9 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03518242.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.