Breast CancerMotHERNCT00833963
A Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Trastuzumab, Pertuzumab in Combination With Trastuzumab, or Ado-Trastuzumab Emtansine
An observational study of Breast Cancer and Pregnancy, run by Genentech, Inc. at 1 site in United States.
Trial summary
The MotHER Pregnancy Registry is a United States (U.S.)-based, prospective, observational cohort study in women with breast cancer who have been or are being treated with a trastuzumab (herceptin)-containing regimen with or without pertuzumab (perjeta) or ado-trastuzumab emtansine (kadcyla) during pregnancy or within… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Pregnancy
- What is being tested?
- Trastuzumab, Pertuzumab and Ado-Trastuzumab Emtansine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2009to 13 Apr 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: This study is recruiting participants from anywhere within the United States. No office visits are required to participate in this registry. Information is collected from participants based on their medical charts.
Who may be able to join
- Pregnant; women identified at any trimester of pregnancy may enroll in this study as long as enrollment occurs prior to experiencing pregnancy outcome (that is [i.e.], live birth, stillbirth, or abortion)
- Exposure to at least one dose of trastuzumab (as adjuvant or metastatic treatment), pertuzumab plus trastuzumab combination treatment, or ado-trastuzumab emtansine during pregnancy or within 7 months prior to conception
- United States resident
Who cannot join
- Prior knowledge of pregnancy outcome (i.e., live birth, stillbirth, or abortion) at time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Kendle International, Inc
Wilmington, North Carolina, 28405
About this study
Official title: An Observational Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Herceptin, Perjeta in Combination With Herceptin, or Kadcyla During Pregnancy or Within 7 Months Prior to Conception
The MotHER Pregnancy Registry is a United States (U.S.)-based, prospective, observational cohort study in women with breast cancer who have been or are being treated with a trastuzumab (herceptin)-containing regimen with or without pertuzumab (perjeta) or ado-trastuzumab emtansine (kadcyla) during pregnancy or within 7 months prior to conception (regardless of cancer stage at the time of trastuzumab, pertuzumab, or ado-trastuzumab emtansine exposure).
- Conditions
- Breast Cancer, Pregnancy
- Being tested
- Trastuzumab, Pertuzumab, Ado-Trastuzumab Emtansine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Also called Herceptin
Participants will receive trastuzumab as determined by their treating physicians' standards of care.
PertuzumabDrug
Also called Perjeta
Participants will receive pertuzumab as determined by their treating physicians' standards of care.
Ado-Trastuzumab EmtansineDrug
Also called Kadcyla
Participants will receive ado-trastuzumab emtansine as determined by their treating physicians' standards of care.
| Study group | Role | What they receive |
|---|---|---|
| Participants Treated With Trastuzumab | Participants who are being treated with trastuzumab during pregnancy or within 7 months prior to conception will be evaluated for cancer and pregnancy as determined by their treating physicians' standards of care, and will be observed for up to 12 months after delivery. Receives: Drug: Trastuzumab | |
| Participants Treated With Trastuzumab and Pertuzumab | Participants who are being treated with the combination of trastuzumab and pertuzumab during pregnancy or within 7 months prior to conception will be evaluated for cancer and pregnancy as determined by their treating physicians' standards of care, and will be observed for up to 12 months after delivery. Receives: Drug: Trastuzumab; Drug: Pertuzumab | |
| Participants Treated With Ado-Trastuzumab Emtansine | Participants who are being treated with ado-trastuzumab emtansine during pregnancy or within 7 months prior to conception will be evaluated for cancer and pregnancy as determined by their treating physicians' standards of care, and will be observed for up to 12 months after delivery. Receives: Drug: Ado-Trastuzumab Emtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Developing Oligohydramnios
Measured: From enrollment up to the delivery or upon termination of pregnancy (up to 12 months)
Number of Live Births
Measured: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
Number of Fetal Deaths/Stillbirths
Measured: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
Number of Fetal or Infant Major Malformations
Measured: From delivery up to 12 months after delivery
Number of Fetal or Infant Deformations
Measured: From delivery up to 12 months after delivery
Number of Fetal or Infant Disruptions
Measured: From delivery up to 12 months after delivery
Number of Fetal or Infant Functional Deficits
Measured: From delivery up to 12 months after delivery
Secondary outcomes (6)
Number of Spontaneous Abortions
Measured: From enrollment up to 12 months
Number of Therapeutic Abortions, or Elective Abortions
Measured: From enrollment up to 12 months
Number of Premature Births
Measured: From enrollment up to 12 months
Number of Infants Small for Gestational Age
Measured: From delivery up to 12 months after delivery
Number of Cases of Intrauterine Growth Restriction (IUGR)
Measured: From enrollment up to 12 months
Number of Other Specific Pregnancy or Delivery Complications
Measured: From enrollment up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study start14 Jan 2009
- Primary completion13 Apr 2017
- Study completion13 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vikki Brown, M.D., Study director, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833963
- Sponsor's protocol ID
- H4621g
- Acronym
- MotHER
- Status last verified
- May 2019
- First submitted
- 30 Jan 2009
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599.
PubMed 35594464
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Herceptin, Perjeta in Combination With Herceptin, or Kadcyla During Pregnancy or Within 7 Months Prior to Conception
- ClinicalTrials.gov ID
- NCT00833963
- Acronym / sponsor ID
- MotHER / H4621g
- Conditions
- Breast Cancer, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2009 (actual)
- Primary completion
- 13 Apr 2017 (actual)
- Study completion
- 13 Apr 2017 (actual)
- First posted
- 2 Feb 2009 (estimated)
- 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.
The MotHER Pregnancy Registry is a United States (U.S.)-based, prospective, observational cohort study in women with breast cancer who have been or are being treated with a trastuzumab (herceptin)-containing regimen with or without pertuzumab (perjeta) or ado-trastuzumab emtansine (kadcyla) during pregnancy or within 7 months prior to conception (regardless of cancer stage at the time of trastuzumab, pertuzumab, or ado-trastuzumab emtansine exposure).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants Treated With Trastuzumab | – | Drug: TrastuzumabParticipants who are being treated with trastuzumab during pregnancy or within 7 months prior to conception will be evaluated for cancer and pregnancy as determined by their treating physicians' standards of care, and will be observed for up to 12 months after delivery. |
| Participants Treated With Trastuzumab and Pertuzumab | – | Drug: Trastuzumab, Drug: PertuzumabParticipants who are being treated with the combination of trastuzumab and pertuzumab during pregnancy or within 7 months prior to conception will be evaluated for cancer and pregnancy as determined by their treating physicians' standards of care, and will be observed for up to 12 months after delivery. |
| Participants Treated With Ado-Trastuzumab Emtansine | – | Drug: Ado-Trastuzumab EmtansineParticipants who are being treated with ado-trastuzumab emtansine during pregnancy or within 7 months prior to conception will be evaluated for cancer and pregnancy as determined by their treating physicians' standards of care, and will be observed for up to 12 months after delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is recruiting participants from anywhere within the United States. No office visits are required to participate in this registry. Information is collected from participants based on their medical charts.
Key inclusion criteria (3 listed)
- Pregnant; women identified at any trimester of pregnancy may enroll in this study as long as enrollment occurs prior to experiencing pregnancy outcome (that is [i.e.], live birth, stillbirth, or abortion)
- Exposure to at least one dose of trastuzumab (as adjuvant or metastatic treatment), pertuzumab plus trastuzumab combination treatment, or ado-trastuzumab emtansine during pregnancy or within 7 months prior to conception
- United States resident
Key exclusion criteria (1 listed)
- Prior knowledge of pregnancy outcome (i.e., live birth, stillbirth, or abortion) at time of enrollment
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 |
|---|---|---|
| TrastuzumabAlso: HerceptinParticipants will receive trastuzumab as determined by their treating physicians' standards of care. | Drug | Participants Treated With Trastuzumab, Participants Treated With Trastuzumab and Pertuzumab |
| PertuzumabAlso: PerjetaParticipants will receive pertuzumab as determined by their treating physicians' standards of care. | Drug | Participants Treated With Trastuzumab and Pertuzumab |
| Ado-Trastuzumab EmtansineAlso: KadcylaParticipants will receive ado-trastuzumab emtansine as determined by their treating physicians' standards of care. | Drug | Participants Treated With Ado-Trastuzumab Emtansine |
Primary outcome
Number of Participants Developing Oligohydramnios
Time frame: From enrollment up to the delivery or upon termination of pregnancy (up to 12 months)
Number of Live Births
Time frame: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
Number of Fetal Deaths/Stillbirths
Time frame: From Week 20 of gestation to the delivery or upon termination of pregnancy (up to 12 months)
Number of Fetal or Infant Major Malformations
Time frame: From delivery up to 12 months after delivery
Number of Fetal or Infant Deformations
Time frame: From delivery up to 12 months after delivery
Number of Fetal or Infant Disruptions
Time frame: From delivery up to 12 months after delivery
Number of Fetal or Infant Functional Deficits
Time frame: From delivery up to 12 months after delivery
6 secondary outcomes
Number of Spontaneous Abortions
Time frame: From enrollment up to 12 months
Number of Therapeutic Abortions, or Elective Abortions
Time frame: From enrollment up to 12 months
Number of Premature Births
Time frame: From enrollment up to 12 months
Number of Infants Small for Gestational Age
Time frame: From delivery up to 12 months after delivery
Number of Cases of Intrauterine Growth Restriction (IUGR)
Time frame: From enrollment up to 12 months
Number of Other Specific Pregnancy or Delivery Complications
Time frame: From enrollment up to 12 months
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 16 May 2019.
- Derived from this study: PubMed 35594464Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599.
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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.
Vikki Brown, M.D. study director
Syneos Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Pregnancy, run by Genentech, Inc. at 1 site in United States.
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 3 inclusion and 1 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 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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?
Number of Participants Developing Oligohydramnios (time frame: From enrollment up to the delivery or upon termination of pregnancy (up to 12 months)). The study lists 7 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 NCT00833963, which also lists 1 linked publication.
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 16 May 2019.